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Last update 23 Oct 2026
Pertuzumab
Last update 23 Oct 2026
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms 2C4 Antibody, Anti-2C4 monoclonal antibody, Monoclonal Antibody 2C4 + [16] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (08 Jun 2012), |
RegulationAccelerated Approval (United States), Orphan Drug (United States) |
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Structure/Sequence
Sequence Code 18492L
Source: *****
Sequence Code 18505H
Source: *****
Related
367
Clinical Trials associated with PertuzumabNCT07578116
Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy
This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.
Start Date09 Mar 2027 |
Sponsor / Collaborator  SWOG [+1] |
NCT07772245
Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer
The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate [residual cancer burden (RCB)- 0] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.
Start Date31 Dec 2026 |
Sponsor / Collaborator |
NCT07679269
An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.
Start Date15 Dec 2026 |
Sponsor / Collaborator |
100 Clinical Results associated with Pertuzumab
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100 Translational Medicine associated with Pertuzumab
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100 Patents (Medical) associated with Pertuzumab
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1,877
Literatures (Medical) associated with Pertuzumab01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Development and application of antibody framework region-targeted cross-linking mass spectrometry for epitope screening within patient-derived immune complexes
Article
Author: Aibara, Nozomi ; Nakamura, Minoru ; Ohyama, Kaname ; Matsugi, Yuya ; Kutsuna, Yuki Jimbayashi ; Hamasaki, Maya ; Kawakami, Atsushi ; Yamazawa, Ryuji ; Nakashima, Mikiro
Identification of antibody-binding epitopes on antigens is essential for understanding the pathogenic roles of immune complexes (ICs) in autoimmune diseases and for the development of diagnostics and therapeutics. However, methods for direct epitope characterization of IC-antigens formed in vivo remain limited. Here, we investigated antibody framework region (FR)-targeted cross-linking mass spectrometry (XL-MS) as an approach to identify epitopes in patient-derived ICs. Four IC models with known epitopes (tumor necrosis factor alpha-adalimumab, tumor necrosis factor alpha-infliximab, human epidermal growth factor receptor 2-pertuzumab, and human epidermal growth factor receptor 2-trastuzumab) were analyzed using three cross-linkers of different lengths: bis(sulfosuccinimidyl) suberate (BS3), bis(sulfosuccinimidyl) glutarate (BS2G), and 1,1'-carbonyldiimidazole (CDI). BS3 preferentially generated antigen-FR cross-links, whereas CDI predominantly produced antigen-complementarity-determining region cross-links. Several cross-linked peptides contained antigen sequences overlapping previously reported epitopes, supporting the validity of this approach for epitope mapping. As a proof-of-concept clinical application, serum samples from patients with primary biliary cholangitis were analyzed using a targeted database containing four disease-associated autoantigens (PDC-E2, BCOADC-E2, OGDC-E2, and E3BP). Two candidate epitope peptides were identified. One corresponded to a known immunodominant epitope, whereas the other represented a novel candidate site supported by computational epitope prediction analysis. These findings demonstrate that FR-targeted XL-MS provides a strategy for identifying epitopes within patient-derived IC-antigens through the use of conserved antibody FRs. This approach may contribute to understanding antigen recognition mechanisms in autoimmune diseases and support the discovery of disease-relevant therapeutic targets.
01 Dec 2026·BREAST
Impact of anti-HER2 therapies on potentially avoidable deaths from stage II and III HER2-positive breast cancer in the Brazilian public healthcare system
Article
Author: Silveira, Iago ; Pavanel, Eduardo Baldassin ; Ziegelmann, Patricia Klarmann ; Mattar, André ; La Scala, Cintia S Kurokawa ; Cavalcante, Francisco Pimentel ; Correa-Netto, Nelson Francisco
PURPOSE:
Limited access to contemporary anti-HER2 therapies in Brazil's public healthcare system (Sistema Único de Saúde -SUS) may contribute to avoidable mortality among women with HER2-positive early breast cancer. We estimated the number of potentially preventable deaths associated with incorporating adjuvant trastuzumab emtansine (T-DM1) and perioperative pertuzumab into SUS.
METHODS:
We developed a static decision-tree microsimulation model with an 8-year time horizon. The study population was derived from nationwide real-world data from DATASUS, which captures all patients treated within SUS. Three treatment strategies were evaluated: (1) current SUS standard (perioperative trastuzumab only), (2) incorporation of adjuvant T-DM1 for patients with residual invasive disease after neoadjuvant therapy, and (3) a gold-standard regimen including perioperative pertuzumab and response-guided adjuvant T-DM1. Clinical inputs were obtained from the NeoSphere, APHINITY, and KATHERINE trials. Probabilistic sensitivity analysis with 100,000 simulations was performed to estimate mortality outcomes and 95% confidence intervals (CIs).
RESULTS:
A total of 22,432 women with stage II-III HER2-positive breast cancer were identified. The projected mean number of deaths at 8 years was 3606 (95% CI, 3082-4180) under the SUS standard, 2672 (95% CI, 2244-3147) with adjuvant T-DM1, and 2390 (95% CI, 2034-2790) with the gold-standard regimen. Incorporation of T-DM1 was associated with 934 fewer deaths (25.9% relative reduction), whereas full adoption of the gold-standard strategy was associated with 1216 fewer deaths (33.7% relative reduction).
CONCLUSION:
Expanding access to adjuvant T-DM1 and perioperative pertuzumab within SUS could meaningfully reduce mortality and narrow disparities in outcomes for Brazilian women with HER2-positive early breast cancer.
01 Dec 2026·BREAST
Clinical features associated with exceptional response on first-line anti-HER2-based therapy for metastatic breast cancer: real-world data from the ESME national cohort
Article
Author: Mailliez, Audrey ; Bosquet, Lise ; Desmoulins, Isabelle ; Dalenc, Florence ; Gonçalves, Anthony ; Petit, Thierry ; Arnedos, Monica ; Parsons, Heather A ; Bailleux, Caroline ; Lin, Nancy U ; Levy, Christelle ; Jacot, William ; Grinda, Thomas ; Morganti, Stefania ; Bachelot, Thomas ; Carton, Matthieu ; Pierga, Jean-Yves ; Massard, Vincent ; Diéras, Véronique ; Frenel, Jean-Sebastien
Some patients with HER2-positive metastatic breast cancer (MBC) achieve prolonged disease control with first-line anti-HER2-based therapy, but associated clinical features remain poorly characterized in real-world populations. We conducted a retrospective study using the Epidemiological Strategy and Medical Economics (ESME) MBC cohort, including 18 French comprehensive cancer centers. Women with HER2-positive MBC who initiated first-line anti-HER2-based therapy between January 2008 and December 2021 and had at least 3 years of follow-up were eligible. Exceptional responders had no documented progression within 3 years. A secondary analysis evaluated factors associated with remaining progression-free at 5 years. Multivariable logistic regression with bootstrap cross-validation was used. Among 4307 eligible patients, 1016 (23.6%) were exceptional responders. Of 765 evaluable at 5 years, 523 (68.4%) remained progression-free. Factors associated with a lower likelihood of exceptional response included hormone receptor-negative (HR-) disease, a disease-free interval of 6-24 months, ≥3 metastatic sites, visceral metastases, and central nervous system involvement. First-line treatment with chemotherapy, trastuzumab, and pertuzumab was associated with exceptional response. Among exceptional responders, HR-disease, grade III tumors and first-line chemotherapy plus trastuzumab and pertuzumab were associated with progression-free at 5-year, whereas visceral metastases were associated with lower odds. Model discrimination was moderate (AUC 0.72 and 0.64, respectively). Nearly one quarter of patients remained progression-free for at least 3 years, and more than two thirds of those evaluable remained progression-free at 5 years. Clinical variables alone had limited predictive value, supporting the need for molecular and immune biomarkers to better identify this subgroup.
355
News (Medical) associated with Pertuzumab22 Oct 2026
Ad hoc announcement pursuant to Art. 53 LR
Basel, 22 October 2026
Roche continues strong momentum in the third quarter with sales growth of +7% at constant exchange rates (CER) and +8% in CHF; Group sales increase +6% (CER), +1% in CHF, in the first nine months of 2026
Group sales
were +6% at constant exchange rates (CER)
1
, +1% when reported in CHF and +7% in USD
2
, in the first nine months of 2026, driven by high demand for our innovative medicines and diagnostics. In the third quarter, sales grew +7% (CER) and +8% in CHF (+7% in USD), as exchange rates stabilised.
Pharmaceuticals Division sales
were +7% at CER, +2% when reported in CHF and +8% in USD, in the first nine months, due to continued high demand for medicines to treat severe diseases; Xolair (chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers.
Diagnostics Division sales
were +4% at CER, stable when reported in CHF and +6% in USD, in the first nine months, as demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China.
Highlights:
US approval for
Tecentriq
for the adjuvant treatment of stage-III DNA mismatch repair colon cancer,
Gazyva/Gazyvaro
for reducing the risk of relapse in patients 2 years of age and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome and
Enspryng
in thyroid eye disease
US Priority Reviews for
fenebrutinib
in both relapsing and primary progressive multiple sclerosis and
Enspryng
in MOGAD, an autoimmune disease;
vamikibart
filing acceptance in uveitic macular edema, a leading cause of vision loss
EU approval for
Susvimo
in neovascular age-related macular degeneration (nAMD), a severe eye disease, and
Ocrevus
in paediatric relapsing multiple sclerosis; EMA validation of application for
Enspryng
in MOGAD in Europe
Positive data for:
sefaxersen
in an autoimmune condition affecting kidney function (phase III),
Lunsumio
in blood cancer (phase III),
Tam-Peli
in relapsed small-cell lung cancer (phase III) as well as
enicepatide
and
petrelintide
in overweight or obesity and type 2 diabetes (both phase II)
US clearance for
Elecsys pTau217 test
, providing clinicians across primary and specialty care with a single-biomarker blood test to aid in identifying amyloid pathology associated with Alzheimer’s disease
Launch of two new, real-time
PCR tests
to support public health epidemic response to the US outbreak of the Cyclospora cayetanensis parasite
Delivery of
molecular tests
to support the Democratic Republic of the Congo health ministry-led response to the Ebola outbreak
Manufacturing and R&D capacity expansion:
Hillsboro
injectable medicines facility and
Innovation Center Boston for cardiovascular, renal and metabolic diseases
in the US and
small molecules facility
in Basel, Switzerland
Outlook for 2026 confirmed
Roche CEO Thomas Schinecker
: “In the third quarter, we delivered strong sales growth of +7% at constant exchange rates and +8% in Swiss francs.
Most importantly, we continued to make meaningful progress for patients. We advanced another five potential new medicines into the final stage of development this year and now aim to bring up to 20 new medicines to patients by 2030.
The US FDA granted Priority Review for fenebrutinib in both relapsing and primary progressive multiple sclerosis, bringing us closer to delivering the first high-efficacy, brain-penetrant oral therapy to patients. Giredestrant is also under FDA Priority Review in both early-stage and advanced breast cancer, and we are fully prepared to launch later this year, pending approval.
In Diagnostics, we received US FDA clearance for Elecsys pTau217, the first and only FDA-cleared single-biomarker blood test for Alzheimer’s disease that supports both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.
We confirm our full-year outlook.”
Outlook for 2026
Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.
Sales
CHF millions
As % of sales
% change
January–September
2026
2025
2026
2025
At CER
In CHF
In USD
Group
46,493
45,862
100.0
100.0
+6
+1
+7
Pharmaceuticals Division
36,212
35,555
77.9
77.5
+7
+2
+8
United States
18,712
18,798
40.2
41.0
+5
0
Europe
6,819
6,818
14.7
14.9
+2
0
Japan
2,352
2,139
5.1
4.7
+25
+10
International
8,329
7,800
17.9
16.9
+10
+7
Diagnostics Division
10,281
10,307
22.1
22.5
+4
0
+6
International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Group sales
In the first nine months of 2026, Roche
sales
were +6% at CER, +1% when reported in CHF, to CHF 46.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. This currency impact reversed in the third quarter.
Sales growth in the
Pharmaceuticals Division
was +7% at CER, +2% when reported in CHF, to CHF 36.2 billion, with medicines for severe diseases continuing their strong growth.
The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 16.8 billion, an increase of +12% at CER, or +6% in CHF, compared to the first nine months of 2025.
Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) decreased by a combined CHF 0.4 billion at CER, or CHF 0.6 billion in CHF.
In the
United States
, sales were +5% at CER, stable when reported in CHF, due to continued growth of Xolair, Hemlibra, Ocrevus, Polivy (blood cancer) and Tecentriq (cancer immunotherapy). This growth more than compensated for the lower sales of Kadcyla (breast cancer) and Perjeta (breast cancer).
Sales in
Europe
were +2% at CER, stable when reported in CHF, as the growing demand for Ocrevus, Phesgo and Evrysdi (spinal muscular atrophy) more than offset the impact of biosimilar competition on Actemra/RoActemra and the conversion to Phesgo on Perjeta.
In
Japan
, sales were +25% at CER, +10% when reported in CHF, mainly due to product supply to third parties and continued growth of Lunsumio (blood cancer), Hemlibra, Polivy, Elevidys (Duchenne muscular dystrophy) and Vabysmo. There was also a positive impact of timing effects related to the implementation of a new enterprise resource planning (ERP) system.
Sales in the
International
region were +10% at CER, +7% when reported in CHF, led by higher sales of Phesgo, Vabysmo, Hemlibra, Ocrevus and Evrysdi. In China, sales were stable at CER and when reported in CHF, driven by continued growth of Phesgo, Vabysmo, Alecensa and Polivy. The increase was partially offset by lower sales of Perjeta due to the conversion to Phesgo and Xofluza due to a milder flu season in 2025.
The
Diagnostics Division’s
sales were +4% at CER, stable when reported in CHF, to CHF 10.3 billion as growth in demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China.
Sales in the
Europe, Middle East and Africa (EMEA)
region were +3% at CER, unchanged when reported in CHF, driven by higher sales of clinical chemistry and immunodiagnostic products. In
North America
, sales were +9% at CER, +3% when reported in CHF, with growth across the Core Lab, Pathology Lab and Molecular Lab customer areas. Sales in
Asia-Pacific
were -4% at CER, or -8% when reported in CHF, due to the healthcare pricing reforms in China. In
Latin America
, sales growth was +12% at CER, or +11% when reported in CHF.
Pharmaceuticals: key developments
Compound
Milestone
Regulatory
Enspryng
Thyroid eye disease
FDA approves Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)
FDA approval based on phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration.
Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home subcutaneous treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered.
Enspryng is an anti-IL-6R monoclonal antibody using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology.
TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated.
More information:
Media Release
, 16 October 2026
Tecentriq
Different types of cancer
FDA approves Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer
The approval is based on results from the landmark phase III ATOMIC study, published in
The New England Journal of Medicine
, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone.
It is the first approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care.
Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years.
Approval marks the twelfth indication for Tecentriq in the US.
More information:
Media Release
, 9 October 2026
Fenebrutinib
Multiple sclerosis
Fenebrutinib is the first BTK inhibitor to receive US FDA filing acceptance in both relapsing and primary progressive multiple sclerosis
Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in phase III RMS trials (FENhance 1 and 2) while showing a consistent, positive trend in delaying disability.
Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus.
Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression.
If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million people living with MS in the US.
More information:
Media Release
, 30 September 2026
Susvimo
Severe eye diseases
European Commission approves Susvimo for the treatment of neovascular age-related macular degeneration
By continuously delivering medicine into the eye through the Contivue refillable implant, Susvimo is the first and only continuous delivery treatment that offers an alternative to standard-of-care eye injections for nAMD.
Susvimo helps people with nAMD maintain their vision with as few as two treatments per year.
Data from the phase III Archway study showed that Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections.
nAMD is a leading cause of vision loss in adults over 60 and affects approximately 1.7 million people across the European Union.
More information:
Media Release
, 21 September 2026
Enspryng
MOGAD
FDA grants Priority Review for Enspryng for MOGAD, an autoimmune disease with no approved treatments
If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease).
The filing acceptance is based on the phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%.
The European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe, with a decision expected in Q3 2027.
More information:
Media Release
, 10 September 2026
Phase III, pivotal and other key read-outs
Sefaxersen
IgA nephropathy
Positive interim data shows sefaxersen significantly reduces proteinuria in people with IgA nephropathy (IgAN)
In the phase III IMAgINATION study, sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential.
Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage.
Interim data will be presented at an upcoming medical meeting and shared with health authorities.
More information:
Media Release
, 23 September 2026
Enicepatide
Obesity
Roche announces positive phase II results for dual GLP-1/GIP receptor agonist enicepatide in people living with type 2 diabetes and overweight or obesity
At the highest dose (24 mg), enicepatide achieved a mean HbA1c reduction of 2.65% at 48 weeks, highlighting its potential for best-in-disease glycaemic control.
By week 48, 90% of patients in the 24 mg enicepatide arm met the type-2-diabetes glycaemic target of ≤6.5% HbA1c, while 62% achieved normoglycaemia (HbA1c <5.7%).
At the highest 24 mg dose, enicepatide achieved a mean weight loss of 15.5% at 48 weeks, without a weight loss plateau.
More information:
Media Release
, 22 September 2026
Lunsumio
Blood cancer
Regimen based on Lunsumio significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study
Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment.
Data reinforce the potential of this regimen based on Lunsumio to improve clinical outcomes, while offering a tolerable safety profile, a simple dosing schedule and outpatient administration.
CELESTIMO is the confirmatory study required to convert the accelerated approval / conditional marketing authorisation of Lunsumio monotherapy for third-line or later (3L+) follicular lymphoma to full approval, as well as to secure an indication in second-line or later (2L+) follicular lymphoma.
Data will be submitted to health authorities and presented at an upcoming medical meeting.
More information:
Media Release
, 17 September 2026
Tam-Peli
Lung cancer
Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer
Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7%.
The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload is based on MediLink’s proprietary TMALIN platform, designed to maximise antitumour activity while minimising off-target toxicity.
Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong and Macau across multiple tumour types, with plans to rapidly initiate global trials. Tam-Peli has received US FDA and China CDE Breakthrough Therapy Designations for relapsed small-cell lung cancer.
More information:
Media Release
, 13 September 2026
Vabysmo
Severe eye diseases
Vabysmo demonstrates sustained two-year results in a difficult-to-treat form of nAMD
The SALWEEN study showed significant improvements in vision and retinal health.
More than 60% of Asian patients with polypoidal choroidal vasculopathy (PCV), an aggressive subtype of nAMD, treated with Vabysmo showed no signs of polypoidal lesions.
By the end of year two, more than 60% of patients were on an extended 20-week treatment interval, reducing treatment burden.
More information:
Media Release
, 28 August 2026
Other
ESMO presentation
Lung and breast cancer portfolio
Roche to present pivotal data at ESMO 2026, showcasing advances across its lung and breast cancer late-stage portfolio
Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard-of-care, first-generation KRAS G12C inhibitors in previously treated advanced G12C-mutated non-small cell lung cancer.
Patient-reported outcomes from phase III lidERA study showed that improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer.
Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3-targeted ADC, to deliver robust efficacy with a favourable safety pro high-unmet-need solid tumours.
More information:
Media Release
, 19 October 2026
Vamikibart
Uveitic macular edema
Roche presents new phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss
In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks.
UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated.
The FDA has accepted Roche’s Biologics License Application (BLA), with an approval decision expected by July 2027.
More information:
Media Release
, 10 October 2026
Vabysmo
Severe eye diseases
Roche presents new data at EURETINA, highlighting the real-world effectiveness and safety of Vabysmo across major retinal conditions
New real-world results for Vabysmo in nAMD, diabetic macular edema and retinal vein occlusion reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals.
Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care.
With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide.
More information:
Media Release
, 1 October 2026
Giredestrant
Breast cancer
Giredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA data published in
The New England Journal of Medicine
Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus.
By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes.
The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of 30 November 2026 and in advanced disease of 18 December 2026.
More information:
Media Release
, 1 October 2026
Board of Directors nomination
Roche proposes Dr Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to its Board of Directors at the 2027 Annual General Meeting
Roche’s Board of Directors has approved to propose Dr Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board at the Annual General Meeting on 9 March 2027.
Roche Chairman Severin Schwan highlighted Dr Weber’s extensive healthcare industry knowledge and leadership experience as valuable assets for the Board.
Roche continues its commitment to transformative medicines and diagnostics, focusing on major disease areas and global healthcare challenges.
More information:
Media Release
, 23 September 2026
Innovation Center Boston
Roche announces grand opening of its Innovation Center Boston to drive advancements in cardiovascular, renal and metabolic diseases
The centre will be a hub for Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development.
It will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences hubs.
This is part of Roche and Genentech’s USD 50 billion investment in US manufacturing and R&D, building on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon.
More information:
Media Release
, 17 September 2026
Hillsboro facility
Genentech, Roche’s US subsidiary, announces a USD 750 million manufacturing expansion in Hillsboro, Oregon
The new facility in Hillsboro, Oregon for the assembly of injectable medicines and delivery devices will further advance end-to-end US drug manufacturing capabilities.
Approximately USD 750 million investment will double the size of the existing facility and is expected to create an additional 250 specialised manufacturing jobs.
Flexible manufacturing capacity will support advanced drug delivery devices that can provide patients with more convenient ways to receive treatment.
More information:
Media Release
, 20 August 2026
Pharmaceuticals sales
Sales
CHF millions
As % of sales
% change
January–September
2026
2025
2026
2025
At CER
In CHF
Pharmaceuticals Division
36,212
35,555
100.0
100.0
+7
+2
United States
18,712
18,798
51.7
52.9
+5
0
Europe
6,819
6,818
18.8
19.2
+2
0
Japan
2,352
2,139
6.5
6.0
+25
+10
International
8,329
7,800
23.0
21.9
+10
+7
International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Top 20 best-selling pharmaceuticals
(% change at CER
1
)
Total
United States
Europe
Japan
International
CHF m
%
CHF m
%
CHF m
%
CHF m
%
CHF m
%
Ocrevus
Multiple sclerosis
5,317
+7
3,581
+5
1,136
+9
-
-
600
+21
Hemlibra
Haemophilia A
3,750
+12
2,006
+9
769
+5
291
+20
684
+23
Vabysmo
Eye diseases (nAMD, DME, RVO)
3,196
+10
2,060
+2
585
+7
131
+41
420
+65
Tecentriq
Cancer immunotherapy
2,615
+5
1,243
+8
626
-2
245
+6
501
+9
Xolair
3
Chronic hives, food allergies
2,521
+20
2,521
+20
-
-
-
-
-
-
Phesgo
Breast cancer
2,064
+18
486
-1
657
+11
152
+24
769
+43
Perjeta
3
Breast cancer
2,040
-8
824
-10
361
-13
38
-20
817
-3
Actemra/RoActemra
3
RA, COVID-19
1,621
-10
795
-9
328
-26
232
+14
266
-4
Evrysdi
Spinal muscular atrophy
1,470
+18
497
+12
504
+14
65
+7
404
+33
Kadcyla
3
Breast cancer
1,339
-9
442
-19
370
-5
65
+9
462
-2
Polivy
Blood cancer
1,302
+24
606
+29
204
-9
176
+30
316
+44
Alecensa
Lung cancer
1,213
+6
391
-1
189
-3
154
+15
479
+15
MabThera/Rituxan
3
Blood cancer, RA
919
+3
605
+12
94
-8
8
-16
212
-10
Activase/TNKase
3
Cardiac diseases
830
+6
792
+5
-
-
-
-
38
+12
Gazyva/Gazyvaro
3
Blood cancer, lupus nephritis
751
+7
369
+4
176
-2
28
+28
178
+25
Herceptin
3
Breast and gastric cancer
695
-12
140
-15
205
-6
3
-35
347
-13
Avastin
3
Various cancer types
639
-12
195
-8
56
+5
56
-43
332
-9
Columvi
Blood cancer
327
+67
146
+24
92
+113
-
-
89
+167
Enspryng
Acute inflammation of brain, spinal cord and optic nerves
319
+28
79
+18
34
+18
138
+30
68
+42
Pulmozyme
3
Cystic fibrosis
303
-12
214
-11
43
-11
1
+38
45
-18
DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis
Diagnostics key developments
Product
Milestone
Elecsys pTau217
Alzheimer’s disease
Roche receives FDA clearance for Elecsys pTau217, advancing Alzheimer’s disease assessment across primary and specialty care
It is the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.
The test delivers consistency across clinical settings by using the same validated cut-offs in primary and specialty care.
It is designed for broad implementation across Roche’s installed base of more than 4,500 cobas laboratory instruments in the US supporting access through existing laboratory infrastructure.
More information:
Investor Update
, 24 August 2026
Diagnostics sales
Sales
CHF millions
As % of sales
% change
January–September
2026
2025
2026
2025
At CER
In CHF
Diagnostics Division
10,281
10,307
100.0
100.0
+4
0
Customer areas
Core Lab
5,755
5,688
56.0
55.2
+5
+1
Molecular Lab
1,836
1,861
17.9
18.1
+3
-1
Near Patient Care
1,348
1,477
13.1
14.3
-5
-9
Pathology Lab
1,342
1,281
13.0
12.4
+10
+5
Regions
Europe, Middle East, Africa
3,698
3,686
36.0
35.8
+3
0
North America
3,389
3,305
32.9
32.1
+9
+3
Asia-Pacific
2,343
2,547
22.8
24.7
-4
-8
Latin America
851
769
8.3
7.4
+12
+11
More information on Roche’s performance in the first nine months of 2026:
9M 2026 presentation
Appendix with tables
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit
.
All trademarks used or mentioned in this release are protected by law.
References
[1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025.
[2] USD (US dollars). The percentage changes for selected sales figures at US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies.
[3] Products launched before 2015.
Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
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Attachments
Communications appendix tables_YTD Sep 2026_Sales_02102026
Media Investor Release Roche Q3 2026 English
Phase 3Clinical ResultBreakthrough TherapyDrug ApprovalPhase 2
22 Oct 2026
New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer
Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers
TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress.
New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the
DESTINY-Breast05
(
539RO
),
DESTINY-Breast06
(
4279P
),
DESTINY-Breast09
(
LBA49
),
DESTINY-Breast11
(
543RO
) and
DESTINY-Lung04
(
LBA74
) phase 3 trials of Enhertu
®
(trastuzumab deruxtecan) and the
TROPION-Breast02
(
LBA96
) phase 3 trial of Datroway
®
(datopotamab deruxtecan).
Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the
REJOICE-Ovarian01
(
1331P
) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the
REJOICE-Ovarian02
(
1247RO
) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer.
“The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.”
Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases
Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the
DESTINY-Breast09
(
LBA49
) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the
TROPION-Breast02
(
LBA96
) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the
TUXEDO-3
(
690O
) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper.
New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio
Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the
TALENT
(
LBA23
) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the
NeoCOAST-2
(
4244RO
) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the
TROPION-Lung01
(
4451P
) phase 3 trial. Updated findings from the
EPOC2003
(
2888P
) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from
ESPERANZA
(
1014P
), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the
HERTHENA-PanTumor01
(
2073RO
) phase 2 trial also will be presented.
Trials-in-progress poster presentations include the
DESTINY-Breast Guide
(
1795TiP
) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the
TROY
(
1335TiP
) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy.
An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes:
Presentation Title
Author
Abstract
Presentation (CEST)
LBAs
Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer
S. Hurvitz
LBA23
Proffered Paper Presentation
Friday, October 23
1:30 pm – 3:00 pm
First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02
R. Dent
LBA96
Proffered Paper Presentation
Saturday, October 24
8:30 am – 10:00 am
First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04
S. Novello
LBA74
Rapid Oral Presentation
Saturday, October 24
8:30 am – 10:00 am
DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases
C. Saura
LBA49
Rapid Oral Presentation
Monday, October 26
10:15 am – 11:45 am
Breast
DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer
J.F. Boileau
543RO
Rapid Oral Presentation
Friday, October 23
4:15 pm – 5:45 pm
Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer
C. Barrios
539RO
Rapid Oral Presentation
Friday, October 23
4:15 pm – 5:45 pm
Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer
P. Tarantino
4449RO
Rapid Oral Presentation
Monday, October 26
10:15 am – 11:45 am
Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis
G. Curigliano
4279P
Poster Presentation
Friday, October 23
3:15 pm – 4:00 pm
Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106
H. Rugo
1771P
Poster Presentation
Saturday, October 24
12:00 pm – 12:45 pm
DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment
J.Y. Pierga
12P
Poster Presentation
Saturday, October 24
12:00 pm – 12:45 pm
Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool
B. Van der Vegt
1784P
Poster Presentation
Saturday, October 24
12:00 pm – 12:45 pm
Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer
J.S. Frenel
287P
Poster Presentation
Sunday, October 25
12:00 pm – 12:45 pm
A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide)
S. Sammons
1795TiP
Poster Presentation
Saturday, October 24
12:00 pm – 12:45 pm
Lung
NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial
T. Cascone
4244RO
Rapid Oral Presentation
Sunday, October 25
8:30 am – 10:00 am
Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01
N. Girard
4451P
Poster Presentation
Friday, October 23
3:15 pm – 4:00 pm
Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results
M. Ahn
3842P
Poster Presentation
Monday, October 26
12:00 pm – 12:45 pm
Ovarian
Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study
A. Oaknin
1247RO
Rapid Oral Presentation
Saturday, October 24
08:30 am – 10:00 am
Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01
K. Hasegawa
1331P
Poster Presentation
Monday, October 26
12:00 pm – 12:45 pm
A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14)
J.Y. Lee
1335TiP
Poster Presentation
Monday, October 26
12:00 pm – 12:45 pm
Gastric
Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04
M. Gumus
2925P
Poster Presentation
Sunday, October 25
12:00 pm – 12:45 pm
Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003)
D. Takahari
2888P
Poster Presentation
Sunday, October 25
12:00 pm – 12:45 pm
PanTumor
Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease
M. Preusser
690O
Proffered Paper Presentation
Sunday, October 25
10:15 am – 11:45 am
Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01
M. McKean
2073RO
Rapid Oral Presentation
Sunday, October 25
10:15 am – 11:45 am
ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors
F. Meric-Bernstam
1014P
Poster Presentation
Friday, October 23
3:15 pm – 4:00 pm
About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.
The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.
Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload.
Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo
Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit
.
Contacts
MEDIA CONTACTS:
Global:
Jennifer Brennan
Jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)
Japan:
DS-PR_jp@daiichisankyo.com
INVESTOR RELATIONS CONTACT:
DaiichiSankyoIR_jp@daiichisankyo.com
Phase 2Phase 3Clinical ResultADCImmunotherapy
19 Oct 2026
CLARITY-Gastric01 data will demonstrate potential of Sone-Ve to establish new treatment for broad population of CLDN18.2-positive gastric cancer patients
SAFFRON results will highlight clinical benefit of adding savolitinib to backbone TAGRISSO in MET-driven 2nd-line EGFRm lung cancer
VOLGA and DeLLphi-305 data will showcase the transformative potential of combining IMFINZI with novel agents to set new standards of care in bladder and small cell lung cancer
AstraZeneca advances its ambition to revolutionize cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, October 23-27, 2026.
More than 100 abstracts will be presented, including data from five pivotal Phase III trials, four of which will be featured in Presidential Symposia. This breadth of data will demonstrate how AstraZeneca is redefining the way cancer is treated with innovative combinations, precision medicine and antibody drug conjugates (ADCs) across bladder, lung and gastric cancers. Highlights include:
CLARITY-Gastric01: Phase III trial of sonesitatug vedotin (Sone-Ve), a wholly owned Claudin-18.2 (CLDN18.2) ADC, in 2nd and later-line CLDN18.2-positive (≥25%) advanced gastric or gastroesophageal junction (GEJ) cancers versus investigator’s choice of therapy. This is the first Phase III trial to show a statistically significant and clinically meaningful overall survival (OS) benefit with an anti-CLDN18.2 ADC in this setting. Approximately 60% of patients have CLDN18.2 expression ≥25% in this setting. (Presidential Symposium 2 Abstract #LBA7).
CLARITY-Gastric01: Phase III trial of sonesitatug vedotin (Sone-Ve), a wholly owned Claudin-18.2 (CLDN18.2) ADC, in 2nd and later-line CLDN18.2-positive (≥25%) advanced gastric or gastroesophageal junction (GEJ) cancers versus investigator’s choice of therapy. This is the first Phase III trial to show a statistically significant and clinically meaningful overall survival (OS) benefit with an anti-CLDN18.2 ADC in this setting. Approximately 60% of patients have CLDN18.2 expression ≥25% in this setting. (Presidential Symposium 2 Abstract #LBA7).
SAFFRON: Phase III trial of TAGRISSO® (osimertinib) plus savolitinib in patients with MET-driven, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who progressed on prior treatment versus platinum-based chemotherapy (Presidential Symposium 2 Abstract #LBA6).
SAFFRON: Phase III trial of TAGRISSO® (osimertinib) plus savolitinib in patients with MET-driven, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who progressed on prior treatment versus platinum-based chemotherapy (Presidential Symposium 2 Abstract #LBA6).
DeLLphi-305: Amgen-led Phase III trial of IMFINZI® (durvalumab) plus tarlatamab-dlle as a 1st-line maintenance treatment for extensive-stage small cell lung cancer versus IMFINZI alone (Presidential Symposium 1 Abstract #LBA3).
DeLLphi-305: Amgen-led Phase III trial of IMFINZI® (durvalumab) plus tarlatamab-dlle as a 1st-line maintenance treatment for extensive-stage small cell lung cancer versus IMFINZI alone (Presidential Symposium 1 Abstract #LBA3).
VOLGA: Phase III trial of perioperative IMFINZI in combination with neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy, versus surgery with or without approved adjuvant treatment (Presidential Symposium 1 Abstract #LBA2).
VOLGA: Phase III trial of perioperative IMFINZI in combination with neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy, versus surgery with or without approved adjuvant treatment (Presidential Symposium 1 Abstract #LBA2).
SANOVO: Hutchmed-led Phase III trial of TAGRISSO plus savolitinib in treatment-naïve patients with MET-overexpressed, EGFRm locally advanced or metastatic NSCLC versus TAGRISSO alone in China (Proffered Paper Abstract #LBA69). NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase II perioperative trial of IMFINZI combinations with DATROWAY® (datopotomab deruxtecan-dlnk), oleclumab and monalizumab in NSCLC (Rapid Oral Session Abstract #4244RO). FONTANA: Phase I/IIa trial of torvutatug samrotecan (Torvu-Sam), a folate receptor α (FRα)-targeting ADC as monotherapy in patients with platinum-resistant recurrent ovarian cancer (Rapid Oral Session Abstract #1245RO)
SANOVO: Hutchmed-led Phase III trial of TAGRISSO plus savolitinib in treatment-naïve patients with MET-overexpressed, EGFRm locally advanced or metastatic NSCLC versus TAGRISSO alone in China (Proffered Paper Abstract #LBA69).
NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase II perioperative trial of IMFINZI combinations with DATROWAY® (datopotomab deruxtecan-dlnk), oleclumab and monalizumab in NSCLC (Rapid Oral Session Abstract #4244RO).
FONTANA: Phase I/IIa trial of torvutatug samrotecan (Torvu-Sam), a folate receptor α (FRα)-targeting ADC as monotherapy in patients with platinum-resistant recurrent ovarian cancer (Rapid Oral Session Abstract #1245RO)
AZD7003: Updated results from a Phase I trial of C-CAR031, a Glypican 3 (GPC3) CAR-T, in advanced hepatocellular carcinoma (Rapid Oral Session Abstract #1680RO).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "AstraZeneca’s portfolio of scientific data at ESMO is our strongest to date, showcasing transformative combinations including emerging modalities. Findings from VOLGA, DeLLphi-305 and SAFFRON demonstrate the potential of combination regimens with complementary mechanisms to improve on today’s standards of care, extend treatment benefit and meaningfully improve survival outcomes for more patients. These data, alongside practice-changing results for our first wholly owned ADC Sone-Ve from CLARITY-Gastric01 underscore how AstraZeneca is transforming cancer care.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “At ESMO, we are presenting pivotal data that demonstrate how we are advancing new standards of care by adding novel medicines to AstraZeneca’s proven backbone therapies. Results from VOLGA, DeLLphi-305 and SAFFRON highlight the potential of innovative IMFINZI- and TAGRISSO-based regimens to improve outcomes for patients across bladder and lung cancers, reinforcing our commitment to continually raising the bar for patients with cancer across the treatment landscape."
Key AstraZeneca presentations during ESMO 20261
Lead Author
Abstract Title
Presentation details (CEST)
Antibody drug conjugates
Xu, R-H
CLARITY-Gastric01 (CG-01): a Phase III trial of Sone-Ve in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC)
Abstract #LBA7
Presidential Symposium 2
October 25, 2026
4:30 PM
Meric-Bernstam, F
Updated results from FONTANA: Torvutatug samrotecan (torvu-sam), a folate receptor α (FRα)-targeted antibody-drug conjugate (ADC), in patients (pts) with platinum-resistant ovarian cancer (PROC)
Abstract #1245RO
Rapid Oral Session
October 24, 2026
Dent, R
First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02 (TB-02)
Abstract #LBA96
Proffered Paper Session
October 24, 2026
8:30 AM
Boileau, JF
DESTINY-Breast11 (DB-11): MRI-assessed objective responses during neoadjuvant treatment (NAT) with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-
dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in HER2+ early breast cancer (eBC)
Abstract #543RO
Rapid Oral Session
October 23, 2026
4:15 PM
Novello, S
First-line (1L) trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-mutant (HER2m) NSCLC: Patient-reported outcomes (PROs) from DESTINY-Lung04 (DL-04)
Abstract #LBA74
Rapid Oral Session
October 24, 2026
9:00 AM
Manich, S
A DESTINY-Breast09 (DB-09) analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC) and baseline (BL) brain metastases (BMs)
Abstract #LBA49
Rapid Oral Session
October 26, 2026
10:15 AM
Immuno-oncology
Powles, T
Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: results from the Phase 3 VOLGA trial
Abstract #LBA2
Presidential Symposium 1
October 24, 2026
4:30 PM
Sands, J
Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial
Abstract #LBA3
Presidential Symposium 1
October 24, 2026
4:30 PM
Kudo, M
Liver function trajectory and post-progression outcomes in the Phase III EMERALD-3 trial of tremelimumab (T) + durvalumab (D) ± lenvatinib
(L) + transarterial chemoembolisation (TACE) in participants (pts) with
embolisation-eligible hepatocellular carcinoma (eeHCC)
Abstract #LBA48
Proffered Paper Session
October 24, 2026
10:15 AM
Westin, S
Durvalumab (D) plus carboplatin/paclitaxel (CP) followed by D with or without olaparib (O) in advanced/recurrent endometrial cancer (a/rEC): interim overall survival (OS) and safety from the randomized Phase III DUO-E/GOG-3041/ENGOT-EN10 trial
Abstract #LBA37
Proffered Paper Session
October 24, 2026
2:45 PM
De Santis, M
Durvalumab (D) in Combination With BCG Induction and Maintenance (I+M) for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): Early Recurrence and Cystectomy-Free Survival in Patients (pts) With Papillary Only Tumours From POTOMAC
Abstract #4737RO
Rapid Oral Session
October 24, 2026
10:15 AM
Cascone, T
NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase II perioperative trial
Abstract #4244RO
Rapid Oral Session
October 25, 2026
8:30 AM
Spicer, J
ctDNA clearance (CL) during neoadjuvant treatment (neoadj Tx) and its association with outcomes in patients (pts) with resectable/borderline resectable stage IIB–IIIB NSCLC from MDT-BRIDGE
Abstract #LBA62
Rapid Oral Session
October 26, 2026
10:15 AM
Lorenza, R
Seven-year overall survival (OS) and OS by tumour response measures from the Phase III HIMALAYA trial of tremelimumab plus durvalumab in first-line (1L) unresectable hepatocellular carcinoma (uHCC)
Abstract #1683P
Poster Session
October 25, 2026
12:00 PM
Tumor drivers and resistance
Lu, S
Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase III primary results
Abstract #LBA6
Presidential Symposium 2
October 25, 2026
4:30 PM
Wu, YL
Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase III SANOVO trial
Abstract #LBA69
Proffered Paper Session
October 26, 2026
8:30 AM
Fizazi, K
Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN-deficient metastatic hormone sensitive prostate cancer (mHSPC): updated overall survival (OS) from CAPItello-281
Abstract #LBA56
Rapid Oral Session
October 23, 2026
1:30 PM
Cell therapy
Liang, T
Phase I trial of C-CAR031, a GPC3-targeted TGFβRIIDN armored autologous CAR-T, in advanced hepatocellular carcinoma (aHCC): Updated Results
Abstract #1680RO
Rapid Oral Session
October 26, 2026
2:45 PM
1 More than 100 abstracts at ESMO 2026 will feature AstraZeneca medicines and pipeline molecules
IMPORTANT SAFETY INFORMATION for TAGRISSO® (osimertinib)
There are no contraindications for TAGRISSO TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy: In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT): In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%
ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy: In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT): In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%
For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed. For patients who have received recent definitive platinum-based CRT with Grade 1 ILD/pneumonitis, continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≥2 ILD/pneumonitis
TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum‑based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum‑based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed
Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed
Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated
Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated
Myalgia occurred in 4.8% of patients in the pooled safety population who received TAGRISSO as a monotherapy (n=1813), of these, 0.1% were grade 3. Myalgia with concurrent increased creatinine phosphokinase (CPK) elevation occurred in 0.1% of patients. The median time to onset of myalgia for these patients with CPK elevation was 648 days (range: 141 days to 1155 days). Grade 1 myositis occurred in 0.2% of patients who received TAGRISSO. Rhabdomyolysis has been reported in the post-marketing setting. Advise patients to report unexplained muscle pain or tenderness. Monitor CPK levels periodically during treatment with TAGRISSO and as clinically indicated in patients reporting unexplained muscle pain or tenderness. Withhold, then resume at the same or reduced dose
Myalgia occurred in 4.8% of patients in the pooled safety population who received TAGRISSO as a monotherapy (n=1813), of these, 0.1% were grade 3. Myalgia with concurrent increased creatinine phosphokinase (CPK) elevation occurred in 0.1% of patients. The median time to onset of myalgia for these patients with CPK elevation was 648 days (range: 141 days to 1155 days). Grade 1 myositis occurred in 0.2% of patients who received TAGRISSO. Rhabdomyolysis has been reported in the post-marketing setting. Advise patients to report unexplained muscle pain or tenderness. Monitor CPK levels periodically during treatment with TAGRISSO and as clinically indicated in patients reporting unexplained muscle pain or tenderness. Withhold, then resume at the same or reduced dose
Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose
Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose
Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose
Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose
Most common (≥20%) adverse reactions, including laboratory abnormalities, were:
Most common (≥20%) adverse reactions, including laboratory abnormalities, were:
TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue
TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue
TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19
TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19
TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine
TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine
INDICATIONS
TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescribing Information, including Patient Information for TAGRISSO.
IMPORTANT SAFETY INFORMATION FOR IMFINZI® (durvalumab) AND IMJUDO® (tremelimumab-actl)
There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
IMFINZI as a Single Agent In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy. IMFINZI with IMJUDO Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
IMFINZI as a Single Agent Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
IMFINZI as a Single Agent Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies
Adrenal Insufficiency:IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. IMFINZI as a Single Agent Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Hypophysitis:IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. IMFINZI as a Single Agent Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. IMFINZI with IMJUDO Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Thyroid Disorders:IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
IMFINZI as a Single Agent Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
IMFINZI as a Single Agent Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. IMFINZI with IMJUDO Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
IMFINZI as a Single Agent Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
IMFINZI as a Single Agent Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. Endocrine: Hypoparathyroidism. Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection. Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions.
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
IMFINZI as a Single Agent Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
Unresectable Stage III NSCLC
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%). In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC
In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions. In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC
In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%). In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer
In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia. In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer
In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%). In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)
In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%). In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)
In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%). In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer
In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%). In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%). In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)
In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain. In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease. In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis. In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs. In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%). In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test. IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR DATROWAY® (datopotamab deruxtecan-dlnk)
Indications
DATROWAY® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:
adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Contraindications None.
Warnings and Precautions Interstitial Lung Disease/Pneumonitis
DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.
Locally Advanced or Metastatic NSCLC
In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients.
Unresectable or Metastatic Breast Cancer
In the pooled safety population of 443 patients with breast cancer from TROPION-Breast01 and TROPION-PanTumor01, ILD/pneumonitis occurred in 3.6% of patients treated with DATROWAY, including 0.7% of patients with Grade 3. There was one fatal case (0.2%). The median time to onset for ILD was 2.8 months (range: 1.1 months to 10.8 months). Four patients (0.9%) had DATROWAY withheld and 7 patients (1.6%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 60% (9/15) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients.
Patients were excluded from clinical studies for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis.
Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.
Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if ≥Grade 2 ILD/pneumonitis is confirmed.
Ocular Adverse Reactions
DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.
In the pooled safety population, ocular adverse reactions occurred in 36% of patients treated with DATROWAY. Twenty patients (2.2%) experienced Grade 3 ocular adverse reactions, which included keratitis, dry eye, and blurred vision, and one patient experienced a Grade 4 ocular adverse reaction of conjunctival hemorrhage. The most common (≥5%) ocular adverse reactions were dry eye (17%), keratitis (14%), and increased lacrimation (7%). The median time to onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 10% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 3.6% of patients, dosage reductions in 2.5% of patients, and permanent discontinuation of DATROWAY in 1% of patients.
Patients with clinically significant corneal disease were excluded from clinical studies.
Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.
Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated.
Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity.
Stomatitis
DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.
In the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 18.6 months). Stomatitis led to dosage interruption in 6% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.5% of patients.
In patients who received DATROWAY in TROPION-Breast01, 39% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment.
Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.
Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY.
Embryo-Fetal Toxicity
Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.
Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.
Adverse Reactions
The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 927 patients as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This included 137 patients with NSCLC in TROPION-Lung05, 297 patients with NSCLC in TROPION-Lung01, 360 patients with HR-positive, HER2-negative breast cancer in TROPION-Breast01, and 50 patients with NSCLC and 83 patients with breast cancer in TROPION-PanTumor01 (NCT03401385). Among 927 patients who received DATROWAY, 45% were exposed for 6 months or longer and 19% were exposed for greater than one year. In this pooled safety population, the most common (≥20%) adverse reactions were stomatitis (63%), nausea (52%), fatigue (45%), alopecia (38%), constipation (28%), decreased appetite (23%), rash (23%), vomiting (22%), and musculoskeletal pain (20%). In this pooled safety population, the most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (9%) and decreased hemoglobin (3.5%).
Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01
The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 as well as TROPION-PanTumor01 (NCT03401385). Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).
The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.
Serious adverse reactions occurred in 26% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%). Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified.
Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >1% of patients included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%).
Dosage interruptions of DATROWAY due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%).
Dose reductions of DATROWAY due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%) and COVID-19 (1.6%).
The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (71%), nausea (50%), alopecia (49%), fatigue (42%), decreased hemoglobin (34%), decreased lymphocytes (32%), constipation (31%), increased calcium (31%), increased AST (28%), decreased white blood cell count (27%), increased lactate dehydrogenase (23%), musculoskeletal pain (22%), decreased appetite (20%), increased ALT (20%), and rash (20%).
Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included dry skin, blurred vision, abdominal pain, conjunctivitis, dry mouth, ILD/pneumonitis, skin hyperpigmentation, increased lacrimation, and visual impairment.
Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer
TROPION-Breast01
The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY.
Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis.
Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%).
Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%).
Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%).
The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%).
Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis.
Use in Specific Populations
Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus. Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose. Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible. Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients. Geriatric Use: Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients. Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients ≥65 years of age versus younger patients. Renal Impairment: A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min). Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment. The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown. Hepatic Impairment: No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see accompanying full Prescribing Information, including WARNINGS AND PRECAUTIONS, and Medication Guide.
Notes
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Clinical ResultPhase 3Phase 2Phase 1ADC
100 Deals associated with Pertuzumab
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D05446 | Pertuzumab |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 Positive Colorectal Cancer | Japan | 28 Mar 2022 | |
| Early Stage Breast Carcinoma | Australia | 06 May 2013 | |
| Breast Cancer | United States | 08 Jun 2012 | |
| HER2 Positive Breast Cancer | United States | 08 Jun 2012 | |
| Metastatic breast cancer | United States | 08 Jun 2012 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Bladder Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Colorectal Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Gallbladder Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Hematologic Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Lung Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Ovarian Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Pancreatic Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Prostatic Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Salivary Gland Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
| Skin Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | 1,982 | Pertuzumab combined with trastuzumab and chemotherapy | ycueyhyfej(udkrrakxtf) = cfrbctuvui niolthlyaf (ezdimymkxo ) View more | Positive | 23 Oct 2026 | ||
Not Applicable | 132 | cfudupjqdm(jppdtubmxa) = 3 and 5-year OS are 98.8 and 92.4%, in the H arm, and 96.0 and 93.8%, in the HP arm, respectively. szkumkskek (fikkqtwiyg ) View more | Positive | 23 Oct 2026 | |||
Neoadjuvant chemotherapy (NACT) + Trastuzumab (H) | |||||||
Not Applicable | 120 | oinzdqmhwx(uveqmdijed) = ymyaiorwvt wplygelkcb (wwoknkrost ) View more | Positive | 23 Oct 2026 | |||
oinzdqmhwx(uveqmdijed) = tnmyyrgqvj wplygelkcb (wwoknkrost ) View more | |||||||
Not Applicable | 13,352 | tkbamlkjug(xsbykgtpwi) = ssfejtipsx lvaxftgckl (sxnummwwct, 53.8 - 57.3) View more | Positive | 23 Oct 2026 | |||
Not Applicable | 9,187 | THPyro | ictefmkjoq(znwtivgbtf) = msteuziqru hyeapkdbml (zrnvraedxm ) | Positive | 23 Oct 2026 | ||
T-DXd+P | ictefmkjoq(znwtivgbtf) = lgkeuaaocf hyeapkdbml (zrnvraedxm ) | ||||||
Phase 2 | Metastatic Colorectal Carcinoma HER2 overexpression/ERBB2 amplification | 48 | wjzffnwvif(odkqwomnyt) = auzkesoddc ktdlidwnmx (kdopjcreos, 0.38 - 0.64) View more | Positive | 23 Oct 2026 | ||
Phase 2 | 30 | Radiation therapy + IT trastuzumab + pertuzumab | qkiivqsgkc(hurubapvvu) = ovlegeciqv cgahetncaq (hdokwduhgf ) View more | Positive | 23 Oct 2026 | ||
Not Applicable | 78 | xboarimlyr(bihditvyhl) = nlirqracvd ncrdgqghhx (kyqkdsvpdk ) | Positive | 23 Oct 2026 | |||
Not Applicable | 697 | Trastuzumab and taxane | xzwvxalwke(efjfstvbtj) = cbveuofubl wbktdhhvsu (ckrwvazqkc ) View more | Positive | 23 Oct 2026 | ||
xzwvxalwke(efjfstvbtj) = lpcretqcfz wbktdhhvsu (ckrwvazqkc ) View more | |||||||
Not Applicable | 178 | Anthracycline-taxane based chemotherapy with pertuzumab/trastuzumab | khdtrqprbf(idxsxkhqdj) = mbickudqpf eienyqqwsw (awedwdrgot, 3.89 - 12.0) View more | Positive | 23 Oct 2026 |
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