Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT04419181

/ SuspendedPhase 2IIT

A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Start Date11 Aug 2025

Sponsor / Collaborator

University of Rochester

ChiCTR2500099967

/ SuspendedPhase 2IIT

To evaluate the efficacy and safety of trastuzumab biosimilar and pertuzumab biosimilar combined with chemotherapy as neoadjuvant therapy in patients with locally advanced HER2-positive rectal cancer

Start Date26 Apr 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Pertuzumab

100 Translational Medicine associated with Pertuzumab

100 Patents (Medical) associated with Pertuzumab

1,818

Literatures (Medical) associated with Pertuzumab

01 Jun 2025·BREAST

A composite 18F-FDG PET/CT and HER2 tissue-based biomarker to predict response to neoadjuvant pertuzumab and trastuzumab in HER2-positive breast cancer (TBCRC026)

Article

Author: Vaklavas, Christos ; Kachergus, Jennifer M ; Ma, Yaohua ; Winer, Eric ; Valero, Vincente ; Solnes, Lilja B ; Rimawi, Mothaffar ; Denbow, Rita ; Huang, Chiung-Yu ; Storniolo, Anna Maria ; Abramson, Vandana G ; Carter, Jodi M ; Thompson, E Aubrey ; Cimino-Mathews, Ashley ; Stearns, Vered ; Leal, Jeffrey P ; Krop, Ian ; Hennessy, Maeve A ; Wahl, Richard L ; Wolff, Antonio C ; Specht, Jennifer ; Connolly, Roisin M ; Carey, Lisa A

BACKGROUND:

Early metabolic change on PET/CT was predictive of response to neoadjuvant trastuzumab/pertuzumab (HP) in TBCRC026. We hypothesized that a composite biomarker incorporating PET/CT and HER2 tissue-based biomarkers could improve biomarker performance.

METHODS:

83 patients with estrogen receptor-negative/HER2-positive breast cancer received neoadjuvant HP alone [pathologic complete response (pCR) 22 %]. PET/CT was performed at baseline and 15 days post initiation of therapy (C1D15). Promising imaging biomarkers included ≥40 % SULmax decline between baseline and C1D15, and C1D15 SULmax ≤3. Baseline tissue-based biomarkers included HER2-enriched intrinsic subtype (72 %, 46/64; NanoString), tumor HER2 protein abundance (median log2 13.5, range log2 7.1-15.9; NanoString DSP), and HER2 3+ (83 %, 64/77; immunohistochemistry). Logistic regressions were fitted to predict pCR with HER2/PET-CT biomarkers. The C statistic assessed overall prediction power. The optimal composite score cut-off was determined by maximizing Youden's index.

RESULTS:

Factors most predictive for pCR in single predictor models included C1D15 SULmax (OR 0.43; p = 0.007, c = 0.77), % reduction in SULmax (OR 1.03, p = 0.006, c = 0.72) and tumor HER2 protein abundance (OR 1.75; p = 0.01, c = 0.76). The composite of C1D15 SULmax and % reduction in SULmax and their interaction term, had improved probability (c = 0.89 from c = 0.78), with high sensitivity (100 %) and negative predictive value (100 %). The addition of tumor HER2 protein did not further improve prediction power (c = 0.90).

CONCLUSION:

The HER2/PET-CT biomarker had high prediction power for pCR, however was not superior to the prediction power of PET/CT alone. Non-invasive PET/CT biomarkers may facilitate a response-guided approach to neoadjuvant therapy, allowing intensification and de-intensification of treatment, pending further evaluation.

01 Jun 2025·Journal of Cancer Policy

Availability, affordability and health insurance coverage of breast cancer services in Iran - An analysis based on the Universal Health Coverage-Service Planning Delivery and Implementation tool

Article

Author: Bijlmakers, Leon ; Heydari, Majid ; Nouhi, Mojtaba ; Goudarzi, Zahra

BACKGROUND:

As part of efforts to achieve Universal Health Coverage for priority conditions in Iran, it is crucial to evaluate the breast cancer service package and identify aspects that may require adjustment. This study analyzes the current state of breast cancer service supply, service delivery platforms, health insurance coverage, and patient co-payment levels.

METHODS:

The Universal Health Coverage Compendium (UHCC) developed by WHO served to list and distinguish various types of breast cancer services. Information from health insurance agencies in Iran was obtained on actual service provision in the country. The Universal Health Coverage Service Planning Delivery and Implementation (UHC-SPDI) tool was used to assess the scope of breast cancer service delivery in Iran and human workforce levels, and to identify possible gaps in service coverage.

RESULTS:

All 73 actions listed as breast cancer services in the UHC-SPDI are provided in the Iranian healthcare system, with a strong reliance on out-patient centers and hospitals rather than primary health care facilities as service delivery platforms, reflecting suboptimal integration of service delivery. Eighty-seven percent of the services are recognized and accepted by health insurance agencies, with cost coverage levels ranging from 20% for magnetic resonance imaging to 100% for intravenous targeted therapy for metastasis. Genomic tests and four medicines (Pembrolizumab, Pertuzumab, Anastrozole, and Fluorouracil) are not covered by health insurance.

CONCLUSION:

The UHC-SPDI has offered an instrumental framework for a comprehensive assessment of Iran's national breast cancer service package composition by connecting it to the service delivery system and human resources competencies. There is room for improvement of the breast cancer service package in Iran, not only in terms of their health insurance coverage, but also in terms of their actual delivery.

10 Apr 2025·JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab Plus Pertuzumab Versus Cetuximab Plus Irinotecan in Patients With RAS/BRAF Wild-Type, HER2-Positive, Metastatic Colorectal Cancer (S1613): A Randomized Phase II Trial

Article

Author: Hicks, Lee G. ; Esparaz, Benjamin T. ; Alluri, Nitya ; Gold, Philip J. ; Corum, Larry R. ; Denlinger, Crystal S. ; Guthrie, Katherine A. ; Dasari, N. Arvind ; Philip, Philip A. ; Fakih, Marwan ; Kazmi, Syed M. ; Colby, Sarah ; Patel, Mital S. ; Overman, Michael J. ; Tan, Benjamin ; Hochster, Howard S. ; Raghav, Kanwal Pratap Singh ; Gholami, Sepideh ; Chiorean, E. Gabriela ; Kopetz, Scott

PURPOSE:

ERBB2 overexpression/amplification in RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC; human epidermal growth factor receptor 2 [HER2]-positive mCRC) appears to be associated with limited benefit from anti-EGFR antibodies and promising responses to dual-HER2 inhibition; however, comparative efficacy has not been investigated. We conducted a randomized phase II trial to evaluate efficacy and safety of dual-HER2 inhibition against standard-of-care anti-EGFR antibody–based therapy as second/third-line treatment in HER2-positive mCRC.

METHODS:

Patients with RAS/BRAF -WT mCRC after central confirmation of HER2 positivity (immunohistochemistry 3+ or 2+ and in situ hybridization amplified [HER2/CEP17 ratio >2.0]) were assigned (1:1) to either trastuzumab plus pertuzumab (TP; trastuzumab 6 mg/kg and pertuzumab 420 mg once every 3 weeks) or cetuximab plus irinotecan (CETIRI; cetuximab 500 mg/m 2 and irinotecan 180 mg/m 2 once every 2 weeks) until progression or unacceptable toxicity. Crossover to TP was allowed after progression on CETIRI. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR), overall survival, safety, and HER2 gene copy number (GCN ≥20/<20) as a predictive factor.

RESULTS:

Between October 2017 and March 2022, 54 participants were assigned to TP (n = 26) and CETIRI (n = 28). Median PFS did not vary significantly by treatment: 4.7 (95% CI, 1.9 to 7.6) and 3.7 (95% CI, 1.6 to 6.7) months in the TP and CETIRI groups, respectively. Efficacy of TP versus CETIRI differed significantly by HER2 GCN (median PFS, GCN ≥20 [9.9 v 2.9 months] and GCN <20 [3.0 v 4.2 months], respectively; P interaction = .003). On TP, ORR was 34.6% (57.1% with GCN ≥20 v 9.1% with GCN <20) with median GCN of 29.7 versus 13.2 for responders and nonresponders, respectively ( P = .004). Grade ≥3 adverse events occurred in 23.1% and 46.1% of participants with TP and CETIRI, respectively.

CONCLUSION:

TP appears to be a safe and effective cytotoxic chemotherapy-free option for patients with RAS/BRAF -WT, HER2-positive mCRC. Higher levels of HER2 amplification were associated with greater degree of clinical benefit from TP vis-à-vis CETIRI.

147

News (Medical) associated with Pertuzumab

24 Apr 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues good momentum into 2025 with 6% (CER) sales growth in the first quarter

Group sales grew by 6%1 at constant exchange rates (CER; 7% in CHF), driven by high demand for newer medicines and diagnostic solutions.Pharmaceuticals Division sales rose by 8% (9% in CHF) on continued strong demand for a broad range of our medicines; top growth drivers were Phesgo (breast cancer), Vabysmo (severe eye diseases), Xolair (allergies) and Hemlibra (haemophilia A).Diagnostics Division sales remained stable with high demand across products and regions offsetting the impact of the recent healthcare pricing reforms in China.Highlights: US approval for Evrysdi tablet for spinal muscular atrophy and Susvimo for the leading cause of diabetes-related blindnessEU approval for Columvi combination with chemotherapy for people with relapsed or refractory diffuse large B-cell lymphomaUS acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro for lupus nephritisTrontinemab for Alzheimer’s disease and NXT007 for haemophilia A to move into phase IIIExclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise amylin analogue as a stand-alone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388 for weight lossUnveiling of novel sequencing by expansion (SBX) technology, a new class of next-generation sequencingAnnouncement of plans to invest USD 50 billion in pharmaceuticals and diagnostics in the US in R&D and manufacturing over the next five yearsAnnouncement of plans to establish Roche Genentech Innovation Center Boston Outlook for 2025 confirmed Roche CEO Thomas Schinecker: “We had a good start to the year with Group sales increasing by 6% at constant exchange rates and we achieved a number of important milestones. Based on recent data, two potential new therapies – our investigational Brainshuttle bispecific antibody to treat Alzheimer’s and our investigational next-generation haemophilia A medicine – will move into phase III. Together with Zealand Pharma, we are developing amylin as a potential new stand-alone therapy for weight loss and as a fixed-dose combination with our incretin CT-388. In Diagnostics, we unveiled our breakthrough ‘sequencing by expansion’ technology, offering unparalleled speed, throughput and flexibility combined with high accuracy. We are expanding our already strong US footprint – with currently over 25,000 employees, 15 R&D and 13 manufacturing sites – by investing USD 50 billion, an important step to continue to meet patient needs in the US with highly innovative medicines and diagnostics. We are confident we will continue our positive momentum and confirm our full-year outlook.” Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Group 15,440 14,399 100.0 100.0 6 7 Pharmaceuticals Division 11,949 10,921 77.4 75.8 8 9 United States 6,224 5,692 40.3 39.5 6 9 Europe 2,320 2,200 15.0 15.3 5 5 Japan 671 649 4.3 4.5 3 3 International* 2,734 2,380 17.8 16.5 18 15 Diagnostics Division 3,491 3,478 22.6 24.2 0 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). 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. Group salesIn the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China. Sales in the Pharmaceuticals Division increased by 8% (9% in CHF) to CHF 11.9 billion, with newer medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024. Phesgo achieved sales of CHF 0.6 billion due to growing demand across regions, notably China and the US, while Vabysmo continued to witness strong uptake, generating sales of CHF 1.0 billion on increased demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 0.2 billion (CER) due to the impact of loss of exclusivity. In the United States, sales rose by 6%. Xolair, Phesgo, Vabysmo, Polivy (blood cancer) and Ocrevus (multiple sclerosis) were the main growth drivers. This growth more than compensated for the reduced sales of medicines with expired patents and the decline in sales of Tecentriq (cancer immunotherapy). Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo. In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo, PiaSky (rare blood disorder), Tamiflu (influenza) and Alecensa (lung cancer). This growth more than compensated for the impact of price cuts as well as biosimilar erosion. Sales in the International region grew by 18%, led by China. In China, sales rose by 14%, driven by demand for Xofluza and Phesgo. The Diagnostics Division sales remained stable at CHF 3.5 billion as growth in demand, notably for immunodiagnostic products and pathology solutions, offset the impact of the recent healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 4% due to higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, sales rose by 7%, driven by growth across all customer areas. Sales in Asia-Pacific decreased by 15% due to the impact of the healthcare pricing reforms in China. Pharmaceuticals: key developments Compound Milestone Regulatory ColumviBlood cancer European Commission approves Columvi as the first bispecific antibody for diffuse large B-cell lymphoma (DLBCL) after initial therapy The approval is based on the phase III STARGLO study, where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy.DLBCL is an aggressive cancer with a high risk of progression, meaning urgent and effective treatments are needed for people who relapse or have refractory disease.This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant. More information: Media Release, 14 April 2025 Gazyva/GazyvaroLupus nephritis FDA accepts supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of lupus nephritis Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit.The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years. More information: Media Release, 5 March 2025 ColumviBlood cancer CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study.DLBCL – an aggressive disease with a high risk of progression – remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns.If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse. More information: Media Release, 28 February 2025 EvrysdiSpinal muscular atrophy FDA approves Evrysdi tablet as first and only tablet for spinal muscular atrophy (SMA) Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries.Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration. More information: Media Release, 12 February 2025 SusvimoSevere eye diseases FDA approves Susvimo as the first and only continuous-delivery treatment for the leading cause of diabetes-related blindness Susvimo is the first and only continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME).With as few as two treatments per year, Susvimo may help people with DME maintain their vision.Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD). More information: Media Release, 4 February 2025 Phase III, pivotal and other key read-outs TrontinemabAlzheimer’s disease Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in phase Ib/IIa Brainshuttle AD study.Data on the Elecsys pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease.Roche will initiate a phase III programme for trontinemab later this year based on totality of data. More information: Media Release, 3 April 2025 OcrevusMultiple sclerosis Roche provides update on phase III Ocrevus high dose study in people with relapsing multiple sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis.The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed. More information: Media Release, 2 April 2025 XolairAllergies Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies First-ever head-to-head trial comparing Xolair and oral immunotherapyResults were featured as late-breakers at the 2025 AAAAI Annual Meeting.Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies. More information: Media Release, 2 March 2025 Other US investment announcement Roche announces plans to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years USD 50 billion commitment includes new state-of-the-art research and development (R&D) sites, new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California and an additional site location to be announced soon.Investments will create more than 12,000 new jobs: 1,000 at Roche and more than 11,000 in support of new US manufacturing capabilities. Roche already has a significant existing US presence with more than 25,000 employees, 15 R&D centres and 13 manufacturing sites. More information: Media Release, 22 April 2025 Zealand Pharmaagreement Roche enters into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed-dose combination with Roche’s lead incretin asset CT-388.Collaboration will complement Roche’s portfolio in the field of cardiovascular, renal and metabolic (CVRM) diseases.Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035. More information: Media Release, 12 March 2025 Roche Genentech Innovation Center Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston The new centre will be a hub for both 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.Roche will be the first to join Harvard’s Enterprise Research Campus in Allston, taking a suite in the first phase of the project’s cutting-edge lab space.Starting with a lease of 30,000 square feet (approx. 2,800 square metres), Roche intends to invest over the coming years into a research and development presence with eventually up to 500 employees. More information: Media Release, 7 March 2025 Gazyva/GazyvaroLupus nephritis New England Journal of Medicine publishes new data for Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone.Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need.Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease. More information: Media Release, 7 February 2025 Enlarged Corporate Executive Committee change Change to the Roche Enlarged Corporate Executive Committee Wafaa Mamilli joins Roche as Chief Digital Technology Officer (CDTO), reporting to Group CEO Thomas Schinecker.She became a member of the Enlarged Corporate Executive Committee starting 10 February 2025. She is based at Genentech in South San Francisco. More information: Media Release, 29 January 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 11,949 10,921 100.0 100.0 8 9 United States 6,224 5,692 52.1 52.1 6 9 Europe 2,320 2,200 19.4 20.1 5 5 Japan 671 649 5.6 5.9 3 3 International 2,734 2,380 22.9 21.9 18 15 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 1,778 6 1,247 3 344 11 - - 187 16 HemlibraHaemophilia A 1,165 11 610 0 247 7 82 3 226 72 VabysmoEye diseases (nAMD, DME, RVO) 1,018 18 718 7 197 42 32 35 71 101 TecentriqCancer immunotherapy 870 0 411 -8 220 5 81 -5 158 21 Perjeta2Breast cancer 840 -10 342 -3 144 -16 18 -51 336 -9 Xolair2Asthma 645 26 645 26 - - - - - - Actemra/RoActemra2RA, COVID-19 619 -1 294 3 152 -19 71 5 102 26 PhesgoBreast cancer 593 52 179 38 199 18 40 115 175 142 Kadcyla2Breast cancer 506 5 201 5 135 -7 21 -3 149 21 EvrysdiSpinal muscular atrophy 420 18 160 15 145 6 20 0 95 56 AlecensaLung cancer 397 11 130 21 68 -6 49 12 150 12 PolivyBlood cancer 358 42 156 30 94 74 44 2 64 80 MabThera/Rituxan2Blood cancer, RA 298 -16 181 -14 35 -10 3 -17 79 -23 Activase/TNKase2Cardiac diseases 297 -2 285 -2 - - - - 12 -9 Herceptin2Breast and gastric cancer 292 -20 60 -12 77 0 2 -56 153 -29 Avastin2Various cancer types 274 -15 80 -21 14 -33 36 -30 144 -3 Gazyva/Gazyvaro2Blood cancer 249 15 131 27 60 -3 8 46 50 11 XofluzaInfluenza 159 234 14 239 - * - - 145 234 Pulmozyme2Cystic fibrosis 123 10 84 22 18 -9 - -26 21 -10 Tamiflu2Influenza 100 56 9 * 26 114 13 81 52 17 * Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX technology Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions.Combined with an innovative, high-throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable and flexible technology.Reducing the time from sample to genome from days to hours, this novel approach could significantly speed up genomic research, as well as translational and clinical applications in the years to come. More information: Media Release, 20 February 2025 PATHWAY HER2 (4B5) test Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU As seen in the DESTINY-Breast06 trial, approximately 20–25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment. More information: Media Release, 31 January 2025 Diagnostics sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Diagnostics Division 3,491 3,478 100.0 100.0 0 0 Customer areas3 Core Lab 1,904 1,926 54.5 55.4 -1 -1 Molecular Lab 634 611 18.2 17.6 2 4 Near Patient Care 536 569 15.4 16.3 -5 -6 Pathology Lab 417 372 11.9 10.7 11 12 Regions Europe, Middle East, Africa 1,236 1,188 35.4 34.2 4 4 North America 1,154 1,055 33.1 30.3 7 9 Asia-Pacific 853 992 24.4 28.5 -15 -14 Latin America 248 243 7.1 7.0 11 2 More information on Roche performance in the first quarter of 2025: Q1 2025 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharmaceuticals with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis 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. Roche Global Media RelationsPhone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachments 25042025_Roche_Q1_2025_EN Communications appendix tables_Q1 2025 Sales

Phase 3Clinical ResultDrug ApprovalExecutive ChangeLicense out/in

23 Apr 2025

·pmlive.com

AstraZeneca/Daiichi Sankyo’s Enhertu shows promise in first-line HER2-positive breast cancer

AstraZeneca (AZ) and Daiichi Sankyo have shared positive results from a late-stage study of their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-positive metastatic breast cancer. The phase 3 DESTINY-Breast09 study has been evaluating the drug in combination with pertuzumab as a first-line treatment for this patient population. Up to 20% of patients with metastatic breast cancer are affected by HER2-positive disease. Despite HER2-targeted therapies improving outcomes, prognosis remains poor, with the majority of patients experiencing disease progression within two years of first-line treatment with standard-of-care taxane, trastuzumab and pertuzumab (THP). Enhertu, which targets HER2 on cancer cells, is already approved in more than 75 countries globally to treat adults with pre-treated unresectable or metastatic HER2-positive breast cancer. In DESTINY-Breast09, Enhertu plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival compared to THP, with this benefit seen across all pre-specified patient subgroups. Interim overall survival data also showed an early trend favouring Enhertu plus pertuzumab compared to THP, but this was not mature at the time of the planned interim analysis. The safety profile of the Enhertu combination was consistent with the known profiles of the individual therapies. The results make DESTINY-Breast09 the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic breast cancer patient population compared to the current first-line standard of care, according to the companies. Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said the results mark a “significant milestone for patients and [set] the foundation for Enhertu in combination with pertuzumab as an important treatment option in the first-line HER2-positive setting.” Ken Takeshita, global head, research and development, Daiichi Sankyo, added: “The results from DESTINY-Breast09 reinforce the importance of effectively targeting HER2 to achieve durable disease control early in the treatment of HER2-positive metastatic breast cancer. “Building on the positive results seen with Enhertu in the second-line setting, these new findings suggest that starting treatment with Enhertu in combination with pertuzumab at the time of metastatic diagnosis delays disease progression, postponing the time until additional treatment may be needed.” Data from the combination arm of DESTINY-Breast09 will be shared with regulatory authorities, the companies outlined, adding that the second arm evaluating Enhertu monotherapy versus THP remains blinded to patients.

Clinical ResultPhase 3Drug ApprovalADC

22 Apr 2025

·endpts.com

AstraZeneca, Daiichi eye first-line breast cancer market after Enhertu's early Phase 3 win

AstraZeneca and Daiichi Sankyo’s Enhertu cut the risk of progression or death compared with the standard of care for first-line HER2-positive metastatic breast cancer, the companies said Monday. The finding could lead to the antibody-drug conjugate becoming the first new treatment in this setting for over a decade. And if approval in this population is granted, Enhertu will be a step closer to hitting the $5 billion annual peak sales target AstraZeneca has set for it. The partners said that an interim cut from the Phase 3 DESTINY-Breast09 trial showed Enhertu plus Roche’s Perjeta showed a “highly statistically significant and clinically meaningful” improvement in progression-free survival compared with a combination of taxane chemotherapy, Roche’s Herceptin and Perjeta. Both Perjeta and Herceptin target HER2. Herceptin is the antibody on which Enhertu is based. The combination of the two Roche drugs with a taxane has been the standard first-line regimen for HER2-positive metastatic breast cancer, based on data from the CLEOPATRA trial that reported in 2015 . This showed PFS of 18.7 months, and median overall survival of 56.5 months — around 4.7 years. No PFS figures from DESTINY-Breast09 were released, but the partners said that a benefit was seen in all prespecified subgroups. Patient randomization in the trial was stratified by prior treatment (whether patients had metastatic disease when they were diagnosed, versus whether they had progressed on therapy for early-stage disease), hormone receptor status and PIK3CA mutation status. PIK3CA mutations can drive cancer growth. OS data were not mature at the interim analysis, but AstraZeneca and Daiichi said there was an early trend favoring the Enhertu combination on OS versus the control. The safety of Enhertu plus Perjeta was consistent with their individual histories. When full safety data emerge, rates of interstitial lung disease and embryo-fetal toxicity will be watched closely, since Enhertu’s label carries a black box warning of these side effects. DESTINY-Breast09 contains a third arm looking at Enhertu monotherapy, which will also be compared with the current standard. This is still blinded and will continue to the final PFS analysis. Further data from the Perjeta combo arm, however, will come at a medical conference, and will also be filed with regulators. The hit in the combo arm prompted Leerink analysts to update their probability of Enhertu succeeding in this setting from 70% to 85%, according to a Monday note. Around 15% to 20% of patients with metastatic breast cancer have HER2-positive disease, and becoming the first-choice therapy in this setting could expand Enhertu’s sales, which stood at $3.8 billion in 2024. Further clinical successes, though, might be necessary for the ADC’s sales to climb to $5 billion a year. Ongoing Enhertu studies include Destiny-Breast05, in the adjuvant HER2-positive early breast cancer setting, and Destiny-Lung04, in first-line NSCLC with HER2 mutations.

Clinical ResultPhase 3ADC

100 Deals associated with Pertuzumab

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KEGG	Wiki	ATC	Drug Bank
D05446	Pertuzumab	L01XC13	DB06366

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Early Stage Breast Carcinoma	Australia	Roche Products Pty Ltd.	06 May 2013
Breast Cancer	United States	Genentech, Inc.	08 Jun 2012
HER2 Positive Breast Cancer	United States	Genentech, Inc.	08 Jun 2012
Metastatic breast cancer	United States	Genentech, Inc.	08 Jun 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02205047 (INNOVATION, ASCO_GI2025) Manual	Phase 2	HER2-positive gastric cancer HER2 Positive	172	Chemotherapy alone	wnsiozojis(tpdxmhpsnf) = larqzajuwi vdhuqmmmhd (lciidrlyzf ) View more	Negative	23 Jan 2025
				Chemotherapy + Trastuzumab	wnsiozojis(tpdxmhpsnf) = bnxwpblfwo vdhuqmmmhd (lciidrlyzf ) View more
NCT03365882 (S1613, Pubmed) Manual	Phase 2	RAS/BRAF Wild Type HER2 Positive Colorectal Cancer Second line \| Third line HER2 Positive	54	Trastuzumab plus Pertuzumab	abtpbjymmi(kgamhmlzpr) = iizjwiegqb yxycsdzhpi (hwsazntfoo, 1.9 - 7.6) View more	Positive	06 Jan 2025
				Cetuximab plus Irinotecan	abtpbjymmi(kgamhmlzpr) = ksglarvctc yxycsdzhpi (hwsazntfoo, 1.6 - 6.7) View more
NCT05275010 (CTgov)	Phase 1	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	pnlfjcacmd(lpwmrtwqee) = prfnqcdigh zmezfkejch (hgafnqufnq, 27.5) View more	-	23 Sep 2024
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	pnlfjcacmd(lpwmrtwqee) = dcejyhgtqz zmezfkejch (hgafnqufnq, 23.2) View more
ESMO2024	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2	339	TCH	mloxheihdd(rhocvozczs) = nqwbyyuwhh jyrnwccquf (jtgoddlbmx )	Negative	16 Sep 2024
				TCHP	mloxheihdd(rhocvozczs) = kwrwopoxwt jyrnwccquf (jtgoddlbmx )
NCT02091141 (MyPathway, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| Bladder Cancer \| Biliary Tract Neoplasms ... View more	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	qliztgnaxh = lmmgfmyphx yslmhxisaf (djbalpxwiq, yfwgpzdtgj - ckiupukgcn) View more	-	23 Jul 2024
				atezolizumab (Atezolizumab)	qliztgnaxh = rvgmkvpuhi yslmhxisaf (djbalpxwiq, ojbxwhtdlk - abrlpygvvx) View more
NCT06136897 (CTgov)	Phase 2	Malignant Solid Neoplasm	35	Echocardiography Test+Trastuzumab+Pertuzumab	nfhgwidaci = vwkadkclyg urrenmtnhr (diazgwebdg, gwvnhjvygn - yexhsxpoxs) View more	-	25 Jun 2024
NCT05749016 (ASCO2024) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	kmtpwzxbmy(mfrdcqtzsp) = nxpqtztwhk fpynzejgpy (gfdlqbqmrx ) View more	Positive	24 May 2024
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP)	kmtpwzxbmy(mfrdcqtzsp) = udmkfgmxnj fpynzejgpy (gfdlqbqmrx ) View more
NCT04538742 (DESTINY-Breast07, ASCO2024) Manual	Phase 1/2	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2 Positive	130	T-DXd 5.4 mg/kg	tqwcinordg(vidvjgdxxa) = kysiwstvrc wmecutdjmi (fjwvlntnie ) View more	Positive	24 May 2024
				T-DXd 5.4 mg/kg + pertuzumab 420 mg	tqwcinordg(vidvjgdxxa) = tzlhbtgkdq wmecutdjmi (fjwvlntnie ) View more
JPRN-UMIN000027938 \| JPRN-jRCTs021180027 \| NCT03264547 (EMERALD, ASCO 12024 \| ASCO 22024) Manual	Phase 3	HER2 Positive Breast Cancer First line HER2 Positive	446	Eribulin + HP	jplgepwivp(cfdjoxsznx) = cnjgoceoku hslhxnufzb (esywacxbry ) View more	Positive	24 May 2024
				Docetaxel/paclitaxel + HP	jplgepwivp(cfdjoxsznx) = iofigbtwhl hslhxnufzb (esywacxbry ) View more
NCT02693535 (TAPUR, ASCO2024)	Phase 2	Locally Advanced Malignant Solid Neoplasm \| Advanced Malignant Solid Neoplasm \| Multiple Myeloma ERBB2 \| ERBB3	28	Pertuzumab plus trastuzumab (P+T)	nrkjxbbtts(vupdfouwui) = hiebbfbxyq fdejbucvov (qinamaoopm, 43 - 100)	Positive	24 May 2024

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