RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States), Orphan Drug (Japan)

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Sequence Code 31655L

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Clinical Trials associated with Polatuzumab Vedotin-Piiq

NCT06594939

/ Not yet recruitingPhase 2IIT

Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.

Start Date01 Jun 2025

Sponsor / Collaborator

Medical College of Wisconsin

NCT06803693

/ Not yet recruitingPhase 2IIT

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination with POLA-RCHP VERSUS POLA-RCHP in Patients with Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Start Date01 Apr 2025

Sponsor / Collaborator-

NCT06730542

/ RecruitingPhase 1IIT

Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in Patients with Secondary CNS Lymphoma

The purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.

Start Date31 Mar 2025

Sponsor / Collaborator

University of Miami

[+1]

100 Clinical Results associated with Polatuzumab Vedotin-Piiq

100 Translational Medicine associated with Polatuzumab Vedotin-Piiq

100 Patents (Medical) associated with Polatuzumab Vedotin-Piiq

779

Literatures (Medical) associated with Polatuzumab Vedotin-Piiq

01 Dec 2025·Blood Research

Real-world effectiveness and safety of rituximab and reduced-dose CHP with polatuzumab vedotin (pola-R-CHP) in patients aged > 80 years with diffuse large B-cell lymphoma: a retrospective analysis

Article

Author: Tsunoda, Shun ; Kamata, Wataru ; Togano, Tomiteru ; Sato, Shuku ; Tamai, Yotaro

Abstract:

The efficacy and safety of polatuzumab vedotin combined with rituximab, cyclophosphamide, doxorubicin, and prednisolone (pola-R-CHP) in patients aged ≥ 80 years with untreated diffuse large B-cell lymphoma (DLBCL) remain largely unexplored. In this study, we administered a reduced-dose pola-R-CHP regimen to 38 patients with DLBCL aged > 80 years. Extending the findings of the POLARIX trial in this older individuals’ cohort, we conducted a retrospective analysis to assess the efficacy and safety of the treatment in a real-world clinical setting. After 12 months, the overall and progression-free survival rates were 86.2% (95% confidence interval [CI]: 70.0–94.0) and 78.5% (95% CI: 59.2–89.5), respectively. Although the incidence of febrile neutropenia was relatively high (32%), an increased risk was observed in patients with an average relative dose intensity of < 70%, even with reduced treatment intensity. Notably, none of the patients required a dose reduction of polatuzumab vedotin owing to peripheral neuropathy. Therefore, our findings indicate that a reduced-dose pola-R-CHP regimen may be a viable and effective treatment option for older patients newly diagnosed with DLBCL.

01 Apr 2025·BIOORGANIC & MEDICINAL CHEMISTRY

Fine-tuning phenoxy silyl scaffolds for the development of glutathione-responsive prodrugs and antibody–drug conjugates

Article

Author: Qi, Cheng ; Jiang, Yuecheng ; Yu, Xianqiang ; Chen, Hongli ; Wei, Ding ; Wang, Huihui ; Huangfu, Shangwei ; Jiang, Biao

Silyl ether is particularly attractive for application in drug development for its easy preparation, non-toxicity and remarkable biocompatibility. Earlier studies relied on the use of intracellular acidic conditions to induce the cleavage of alkoxy silyl ethers. However, acidic conditions are not suitable to trigger the release of phenoxy silyl ethers, since they are more stable under acidic conditions compared with neutral conditions. We explored the vulnerability of the phenoxy silyl ether towards biological nucleophilic reagents and found that glutathione (GSH) could effectively and selectively induce the cleavage of phenoxy silyl ether. We also demonstrated that the rate of cleavage was controllable by adjusting the substituents on the phenyl ring. Phenoxy silyl ether-based prodrugs and antibody-drug conjugates (ADCs) were designed and synthesized, which could be effectively activated in cells with high GSH levels and there was an obvious therapeutic window between cells with different GSH levels.

01 Apr 2025·Clinical Lymphoma Myeloma & Leukemia

Real-World Effectiveness of Chemoimmunotherapy and Novel Therapies for Patients With Relapsed/Refractory Aggressive Large B-Cell Lymphoma

Article

Author: Huynh, Lynn ; Stanchina, Michele ; Haddadi, Sara ; Duh, Mei Sheng ; Kalsekar, Anupama ; Gao, Chi ; Wang, Yucai ; Lin, Ruitao ; Maurer, Matthew J ; Jun, Monika ; Larson, Melissa A ; Andersen, Clark R ; Kamalakar, Rajesh ; Ayers, Amy ; Flowers, Christopher R ; Nastoupil, Loretta J ; Cerhan, James R ; Martin, Peter ; Habermann, Thomas M ; Cohen, Jonathon B ; Wang, Tongsheng ; Chihara, Dai ; Casulo, Carla ; Koff, Jean L ; Kahl, Brad S ; Ramasubramanian, Ramya ; Lossos, Izidore S ; Link, Brian K ; Mutebi, Alex ; Wang, Anthony ; Ayyappan, Sabarish ; Li, Ziyi

INTRODUCTION:

Clinical trials provide meaningful data regarding the safety and efficacy of novel therapies but there is often a lag between the time of new drug approval and information on posttreatment clinical outcomes in real-world practice. This study evaluated clinical outcomes in a large real-world population of patients with relapsed and/or refractory large B-cell lymphoma (r/r LBCL) treated with chemoimmunotherapy or novel therapies in second or later lines of therapy (2L+).

MATERIALS AND METHODS:

Data from the Lymphoma Epidemiology of Outcomes (LEO) Consortium of Real-World Evidence (CReWE) cohort (1/1/2015-2/15/2023) were analyzed. Patients' demographic and clinical characteristics were described and response rates, duration of response, progression-free survival, and overall survival were evaluated. Multivariable Cox proportional hazards regression models were used to assess associations between patient clinical characteristics and outcomes.

RESULTS:

The 2L+ cohort included patients treated with chemoimmunotherapy (N = 593), lenalidomide-based therapy (n = 60), polatuzumab vedotin-based therapy (N = 116), tafasitamab-based therapy (N = 55), and loncastuximab tesirine (N = 42). Most patients who received prior chimeric antigen receptor T-cell therapy (CAR-T) were refractory to the treatment. Across all patients, overall response rates were <50%, with one-quarter achieving complete response and median duration of response and overall survival were short (<6 and <10 months, respectively) among patients treated with chemoimmunotherapy or novel therapies. The prognosis was worse for patients who had previously received CAR-T. Primary refractory status, high-risk disease, and failing 3 or more lines of therapy were significantly associated with worse outcomes.

CONCLUSION:

Patients with r/r LBCL have unfavorable outcomes and need more effective treatment alternatives.

131

News (Medical) associated with Polatuzumab Vedotin-Piiq

14 Apr 2025

·pipelinereview.com

European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

BASEL, Switzerland I April 14, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. In July 2023, Columvi received a conditional marketing authorisation to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled. “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.” “People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally,” said Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator. “This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.” Approval is based on results from the pivotal phase III STARGLO study, where Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx) in people with R/R DLBCL. 1,2 In the primary analysis (conducted after a median follow-up of 11.3 months), there was a 41% reduction in the risk of death in patients treated with Columvi plus GemOx versus R-GemOx (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011). The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). 1,2 Follow-up analyses were conducted after all patients had completed therapy (median follow-up of 20.7 months), showing a 25.5 month median OS for people treated with the Columvi combination, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). 1,2 Additionally, more than twice as many patients experienced a complete response (58.5% versus 25.3% respectively, with a difference of 33.2% [95% CI: 20.9-45.5]). 1,2 Safety of the combination was consistent with the known safety profiles of the individual medicines. 1,2 DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. In Europe, an estimated 38,000 people are diagnosed with DLBCL each year. 3,4 Approximately four out of ten DLBCL patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes. 5,6 Whilst second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival. 7 Columvi in combination with GemOx offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion in any setting, meaning patients can avoid delays in starting their next treatment. Columvi is also designed to be given for a fixed period offering a target end date for people’s course of therapy and the possibility of a treatment-free period after completion. Columvi, along with Lunsumio® (mosunetuzumab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. About the STARGLO study The STARGLO study [GO41944; NCT04408638 ] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080 ]. About diffuse large B-cell lymphoma (DLBCL) DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL. 3 Approximately 160,000 people worldwide are diagnosed with DLBCL each year. 3,8 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. 5,6 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. 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 Pharma 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] Abramson J, et al. Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Global Randomized Phase III trial (STARGLO). Presented at: EHA Hybrid Congress; 2024 Jun 3-16. Abstract #LB3438. [2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954. [3] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2025 April]. Available from: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics . [4] World Health Organization. Numbers derived from GLOBOCAN 2022. Europe Factsheet [Internet; cited 2025 April]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf . [5] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073. [6] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [7] Fabbri N, Mussetti A and Sureda A. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312. [8] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2025 April]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf . SOURCE: Roche

Phase 3Clinical ResultDrug ApprovalImmunotherapyCell Therapy

14 Apr 2025

·www.pharmaceutical-technology.com

Roche’s Columvi combo gains EC approval for DLBCL

Roche continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL. Credit: © 2022 F. Hoffmann-La Roche Ltd – All rights reserved. Roche has secured approval from the European Commission (EC) for Columvi (glofitamab) plus gemcitabine and oxaliplatin (GemOx) combo to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This authorisation permits the use of the combo for individuals not eligible for autologous stem cell transplant. The approval of the Columvi combo, the first bispecific antibody regimen for DLBCL in Europe, follows a conditional marketing authorisation granted in July 2023 for R/R DLBCL treatment. The decision also satisfies the requirement to transition the present marketing authorisation to a standard approval. The pivotal Phase III STARGLO trial outcomes underpin the EC approval, demonstrating that Columvi plus GemOx significantly improves overall survival compared to MabThera/Rituxan (rituximab) and GemOx (R-GemOx) in R/R DLBCL patients. Columvi plus GemOx provides an off-the-shelf treatment regimen, providing a readily available option for infusion, which can help avoid delays in starting treatment. Columvi and Lunsumio (mosunetuzumab) are a part of the company’s cluster of differentiation 20 (CD20)xCD3 bispecific antibody programme. Roche Global Product Development head and chief medical officer Levi Garraway stated: “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.” Roche’s strategy encompasses the clinical development of allogeneic CAR T-therapies, aiming to offer tailored treatment alternatives for the diverse needs of individuals with blood cancers. Columvi’s design involves a 2:1 structural format, targeting CD3 on T cells and CD20 on B cells. The company continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL. In the Phase III SKYGLO study, it is also being evaluated with Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated DLBCL, to enhance long-term outcomes and relapse prevention. In March 2025, Oxford BioTherapeutics (OBT) entered a multi-year partnership with Roche for antibody-based therapeutics to treat cancer.

ImmunotherapyPhase 3Drug ApprovalBiosimilar

30 Jan 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth

Basel, 30 January 2025 Group sales grew by 7%1 at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics.Excluding COVID-19, Group sales increased by 9%. COVID-19 will not adversely impact our results from 2025 onwards.The fourth quarter was the third consecutive quarter of 9% sales growth, highlighting the very positive momentum.Pharmaceuticals Division sales rose by 8% (excluding COVID-19 medicine: 9%) on growing demand for newer medicines; top growth drivers were Vabysmo (severe eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis) and Hemlibra (haemophilia A).Diagnostics Division sales increased by 4%, reflecting the base effect of the sales of COVID-19 tests in the prior-year period; strong momentum in the Diagnostics Division’s base business continued with an increase of 8% due to higher demand for immunodiagnostic, pathology and molecular solutions.Core operating profit grew by 14% (8% in CHF), driven by higher sales, improved gross margin and effective cost management; core earnings per share rose by 7% (1% in CHF).Core earnings per share excluding the impact of the resolution of tax disputes in 2023 rose by 12%, exceeding the guidance for 2024.IFRS net income decreased by 19% (26% in CHF), mainly due to impairment charges to goodwill related to Flatiron Health and Spark Therapeutics.Operating free cash flow increased by 34% (CER) to CHF 20.1 billion.Highlights: Launch of cobas Mass Spec, a transformative innovation in mass spectrometryEU approval for Vabysmo prefilled syringeUS acceptance of supplemental Biologics License Application for Columvi combinationPositive data on blood cancer medicines Columvi, Lunsumio and Polivy, eye medicine Vabysmo, Duchenne muscular dystrophy medicine Elevidys and breast cancer therapy ItovebiAcquisition of Poseida Therapeutics for a range of potentially first- and best-in-class cell therapies across oncology, immunology and neurologyCE mark for new and updated molecular cobas 6800/8800 systems for enhanced laboratory efficiency and testing capabilities Board proposes dividend increase to CHF 9.70. If approved by shareholders, this would be the 38th consecutive dividend increase. Outlook for 2025 Roche (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. Key figures CHF millions % change January–December 2024 2023 At CER1 In CHF Group sales 60,495 58,716 7 3 Pharmaceuticals Division 46,171 44,265 8 4 Diagnostics Division 14,324 14,451 4 -1 Core operating profit 20,823 19,240 14 8 Core EPS – diluted (CHF) 18.80 18.57 7 1 IFRS net income 9,187 12,358 -19 -26 Roche CEO Thomas Schinecker: “2024 was a strong year for Roche. In the fourth quarter, we continued our very positive momentum for the third consecutive quarter with Group sales growth of 9% (CER). Core earnings per share exceeded the guidance raised at half year. We are proud to have made a positive impact on patients’ lives in 2024 with the launch of two new medicines – Itovebi for a hard-to-treat breast cancer and PiaSky for a serious blood disorder – as well as our new solution for continuous blood glucose monitoring and our innovative system for fully automated mass spectrometry. Last year, we substantially strengthened our pipeline through the acceleration of internal key programmes and new partnerships and acquisitions such as Poseida Therapeutics for cell therapy in oncology and autoimmune diseases. Roche is well positioned for future growth.” Group resultsIn 2024, Roche achieved sales growth of 7% (3% in CHF) to CHF 60.5 billion. Core earnings per share rose by 12%, excluding the base effect of the resolution of tax disputes in 2023. Including this impact, core earnings per share increased by 7%. The appreciation of the Swiss franc against most currencies had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the expected decline of CHF 1.1 billion in COVID-19-related sales and an impact of CHF 1.0 billion 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). Core operating profit rose by 14% (8% in CHF) to CHF 20.8 billion, driven by higher sales, improved gross margin and effective cost management. IFRS net income decreased by 19% (26% in CHF) to CHF 9.2 billion, mainly due to impairment charges to goodwill of CHF 3.2 billion related to Flatiron Health and Spark Therapeutics. Sales in the Pharmaceuticals Division increased by 8% to CHF 46.2 billion, with newer medicines for severe diseases continuing their strong growth. The top four growth drivers – Vabysmo, Phesgo, Ocrevus and Hemlibra – achieved total sales of CHF 16.9 billion. This represents a plus of CHF 3.3 billion at CER compared to 2023. Vabysmo, launched in early 2022, continued to be a major growth driver, generating sales of CHF 3.9 billion on growing demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 1.0 billion (CER) due to the impact of loss of exclusivity. Sales of the COVID-19 medicine Ronapreve were minimal compared to sales in Japan of CHF 0.5 billion in 2023. In the United States, sales rose by 9%. Vabysmo, Ocrevus, Xolair (allergies) and Polivy were the main growth drivers. This growth more than compensated for the decline in sales of Lucentis (severe eye diseases) and lower sales of medicines with expired patents. Sales in Europe grew 8% as sales growth due to the continued rollout of Vabysmo and the uptake of Phesgo, Ocrevus, Hemlibra and Evrysdi (spinal muscular atrophy) more than compensated for the decline in sales of medicines with expired patents, the impact of biosimilar competition on Actemra/RoActemra sales and lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo. In Japan, sales decreased by 16%, reflecting the base effect of Ronapreve sales in the first half of 2023 that did not reoccur in 2024. Excluding Ronapreve, sales in Japan fell by 2% as price cuts and biosimilar and generic erosion more than offset the growth in sales of Phesgo, Vabysmo and Hemlibra. Sales in the International region grew by 17%, led by China, Canada and Brazil. In China, sales rose by 6%, driven by continued sales growth of Perjeta, Alecensa (early-stage lung cancer) and Avastin as well as higher sales of Xofluza (influenza) and the rollout of Polivy. The Diagnostics Division’s base business sales increased by 8%, led by the increased demand for immunodiagnostic products and by higher sales of clinical chemistry tests, advanced staining solutions and companion diagnostics. Overall, the Diagnostics Division reported sales growth of 4% to CHF 14.3 billion, reflecting the anticipated drop in demand for COVID-19-related products (sales of CHF 0.2 billion in 2024 compared to CHF 0.8 billion in 2023). Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, there was growth in the underlying base business across customer areas. Sales in Asia-Pacific decreased by 5% as higher sales of immunodiagnostic products were offset by the expected drop in demand for COVID-19-related tests. Pharmaceuticals Division: pipelineWith 71 new molecular entities (NMEs) and a total of 122 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure grew by 1% to CHF 11.1 billion (Group R&D: 1% to CHF 13.0 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of immunology and cardiovascular, renal and metabolism. Pharmaceuticals: key developments Compound Milestone Regulatory VabysmoSevere eye diseases Vabysmo prefilled syringe (PFS) is now approved in the EU for three retinal conditions that can cause blindness Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials.Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection. More information: Media Release, 13 December 2024 ColumviBlood cancer FDA accepts supplemental Biologics License Application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) The application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival.This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high risk of disease progression.Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who are not eligible for transplant. More information: Media Release, 5 December 2024 Phase III, pivotal and other key read-outs ItovebiBreast cancer Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer Updated results for overall survival (OS) – a key secondary endpoint – reinforce the significant benefit of the regimen based on Itovebi (inavolisib) for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting.Primary analysis showed the regimen based on Itovebi reached statistical significance, more than doubling progression-free survival in this patient population.Full OS results from the phase III INAVO120 study will be presented at an upcoming medical meeting. More information: Media Release, 28 January 2025 ElevidysDuchenne muscular dystrophy Roche announces new results from EMBARK, demonstrating significant sustained benefits of Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD) Across three key functional outcomes, North Star Ambulatory Assessment (NSAA), Time to Rise (TTR) and 10-metre walk/run (10MWR), results were statistically significant and clinically meaningful two years after treatment with Elevidys, compared to a pre-specified propensity-weighted untreated external control group.Functional differences between individuals treated with Elevidys and those in the external control group increased between one year and two years after treatment.No new safety signals were observed, further reinforcing the consistent and manageable safety profile observed with Elevidys to date. More information: Media Release, 27 January 2025 PrasinezumabParkinson’s disease Phase IIb study of prasinezumab misses primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints.Prasinezumab continues to be well tolerated and no new safety signals were observed.Roche is further evaluating the data and will work together with health authorities to determine next steps. More information: Media Release, 19 December 2024 Columvi/LunsumioBlood cancer New and updated data for fixed-duration Columvi and Lunsumio presented at annual meeting of American Society of Hematology (ASH) 2024 reinforce their potential to improve outcomes for people with lymphoma Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing.First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time.Positive results for Roche’s two bispecifics antibodies validate the company’s efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers. More information: Media Release, 10 December 2024 PolivyBlood cancer Five-year results confirm Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for the first-line treatment of people with DLBCL.Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, which potentially reduces the burden on patients and healthcare systems.These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in the first-line treatment of people with DLBCL, an area that had little advancement in nearly two decades. More information: Media Release, 8 December 2024 TiragolumabLung cancer Roche reports update on phase III SKYSCRAPER-01 study results SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). The study did not reach the primary endpoint of overall survival at the final analysis. More information: Media Release, 26 November 2024 VabysmoSevere eye diseases Vabysmo improves vision in under-represented populations with DME in a first-of-its-kind study The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in African American, Black, Hispanic and Latino people with DME treated with Vabysmo. Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies.These racial and ethnic groups are disproportionately affected by diabetes and are at higher risk of developing DME, a leading cause of vision loss. More information: Media Release, 18 October 2024 Other Poseida Therapeutics tender offer Roche purchases shares in tender offer for Poseida Therapeutics Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics at a price of USD 9.00 per share in cash, plus a non-tradeable contingent value right (CVR), to receive certain contingent payments of up to an aggregate of USD 4.00 per share in cash. The tender offer expired at one minute following 11:59 p.m., New York City time, on 7 January 2025, and was not extended. More information: Media Release, 8 January 2025 Poseida Therapeutics tender offer Roche commences tender offer for all shares of Poseida Therapeutics for USD 9.00 per share in cash, plus a non-tradeable contingent value right for up to USD 4.00 per share in cash The tender offer is being made pursuant to the previously announced merger agreement dated 25 November 2024.Following the successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second-step merger at the same price of USD 9.00 per share, plus the contingent value right. The transaction is expected to close in the first quarter of 2025. More information: Media Release, 9 December 2024 Poseida Therapeutics acquisition Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies The acquisition supports Roche’s pharmaceuticals strategy and allows for a range of potentially first- and best-in-class therapies across oncology, immunology and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies.Roche will acquire Poseida Therapeutics for USD 9.00 per share in cash at closing, which represents a total equity value of approximately USD 1.0 billion. Stockholders will also receive a non-tradeable contingent value right for up to an aggregate of USD 4.00 per share in cash, representing a total deal value of up to approximately USD 1.5 billion. More information: Media Release, 26 November 2024 ItovebiBreast cancer NEJM publishes landmark phase III results for Itovebi, showing more than doubling of progression-free survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi (inavolisib) demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study.The FDA recently approved the regimen based on Itovebi as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most common gene mutations in HR-positive disease. More information: Media Release, 31 October 2024 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Pharmaceuticals Division 46,171 44,265 100.0 100.0 8 4 United States 24,774 23,259 53.7 52.5 9 7 Europe 8,832 8,306 19.1 18.8 8 6 Japan 2,874 3,745 6.2 8.5 -16 -23 International* 9,691 8,955 21.0 20.2 17 8 *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 6,744 9 4,819 5 1,306 14 - - 619 29 HemlibraHaemophilia A 4,503 12 2,654 9 926 11 367 8 556 41 VabysmoEye diseases (nAMD, DME, RVO) 3,864 68 2,940 57 622 128 125 40 177 168 TecentriqCancer immunotherapy 3,640 0 1,763 -7 863 4 380 0 634 23 Perjeta3Breast cancer 3,616 1 1,345 3 646 -15 116 -40 1,509 15 Actemra/RoActemra3RA, COVID-19 2,645 5 1,331 11 658 -14 309 9 347 19 Xolair3Asthma 2,470 16 2,470 16 - - - - - - Kadcyla3Breast cancer 1,998 7 765 3 564 -1 98 5 571 23 PhesgoBreast cancer 1,740 62 570 38 738 40 136 ** 296 111 EvrysdiSpinal muscular atrophy 1,631 18 588 19 572 14 93 10 378 25 AlecensaLung cancer 1,548 7 525 15 284 -1 198 3 541 7 Herceptin3Breast and gastric cancer 1,381 -11 265 -18 303 -13 14 -50 799 -6 MabThera/Rituxan3Blood cancer, RA 1,379 -13 842 -13 150 -15 17 -25 370 -10 Avastin3Various cancer types 1,233 -17 383 -19 85 -11 197 -32 568 -10 Activase/TNKase3Cardiac diseases 1,202 5 1,140 5 - - - - 62 5 PolivyBlood cancer 1,121 39 568 70 192 13 198 -4 163 76 Gazyva/Gazyvaro3Blood cancer 910 16 463 20 245 9 29 -15 173 23 Pulmozyme3Cystic fibrosis 455 4 303 2 73 -3 1 21 78 22 CellCept3Immunosuppressant 399 7 23 -22 124 2 40 -3 212 17 Mircera3Anaemia related to kidney disease 397 -3 - - 42 -3 38 -23 317 1 ** 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 cobas liat STI multiplex assay panelsSexually transmitted infections Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to diagnose sexually transmitted infections at the point of care More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralised settings like urgent care centres, retail clinics and community health venues.The tests use highly sensitive gold-standard PCR technology, providing results in 20 minutes to allow healthcare providers to confidently diagnose and determine appropriate treatment in the same visit. More information: Media Release, 22 January 2025 cobas Mass Spec Roche transforms mass spectrometry diagnostics with launch of cobas Mass Spec solution Roche launched its cobas Mass Spec solution, bringing mass spectrometry to the routine clinical lab.Clinical mass spectrometry testing offers unparalleled sensitivity and specificity, providing clinicians with additional diagnostic insights.cobas Mass Spec solution will offer a fully automated, integrated and standardised workflow with IVDR-compliant assays. More information: Media Release, 18 December 2024 cobas 6800/8800 systems 2.0Various tests Roche receives CE mark for new molecular cobas 6800/8800 systems upgrade, enhancing laboratory efficiency and testing capabilities The new cobas 6800/8800 systems 2.0 upgrade enhances throughput and run flexibility, enables sample prioritisation and is available for existing systems in healthcare settings around the world.Laboratories can now perform a wider range of tests on a single solution, thereby simplifying laboratory logistics and helping to optimise the use of resources. More information: Media Release, 13 December 2024 Elecsys Amyloid Plasma PanelAlzheimer’s disease Roche presents new data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, demonstrating its growing momentum in diagnostics for Alzheimer’s disease New data highlight the potential of the Roche Elecsys Amyloid Plasma Panel and Elecsys pTau181 for ruling out Alzheimer’s disease-related amyloid pathology with very good accuracy.In the largest worldwide clinical trial of its kind, the blood-based test showed very good accuracy in ruling out Alzheimer’s pathology in those being investigated for the disease, potentially avoiding the need for further invasive and unnecessary tests.Results further demonstrate Roche’s commitment to bringing diagnostic clarity for Alzheimer’s disease to people at an early stage of cognitive decline. More information: Media Release, 31 October 2024 Diagnostics sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Diagnostics Division 14,324 14,451 100.0 100.0 4 -1 Customer Areas4 Core Lab 8,004 7,750 55.9 53.6 8 3 Molecular Lab5 2,590 2,567 18.1 17.8 4 1 Near Patient Care6 2,167 2,746 15.1 19.0 -17 -21 Pathology Lab 1,563 1,388 10.9 9.6 17 13 Regions Europe, Middle East, Africa 4,822 4,768 33.7 33.0 5 1 North America 4,335 4,173 30.3 28.9 6 4 Asia–Pacific 4,099 4,496 28.6 31.1 -5 -9 Latin America 1,068 1,014 7.4 7.0 22 5 More information on Roche performance in 2024: 2024 Finance Report2024 Annual Report2024 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 Pharma 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 2023) and all total figures quoted are reported in CHF.[2] Pharmaceuticals Division base business: excluding COVID-19 medicine Ronapreve. Diagnostics Division base business: excluding COVID-19-related products.[3] Products launched before 2015.[4] 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.[5] Sales in the Molecular Lab customer area include sales from the Foundation Medicine business, which moved under the responsibility of the Diagnostics Division from the Pharmaceuticals Division effective 1 January 2024. The comparative information for 2023 has been restated accordingly.[6] Sales in the new Near Patient Care customer area include sales from Diabetes Care and the Point of Care business, both previously shown as separate customer areas. The comparative information for 2023 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 8888 / 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 32 17e-mail: kalm.loren@gene.com Attachments 30012025_MR_FY Roche 2024_EN Communications appendix tables_FY 2024 Sales + Results

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

100 Deals associated with Polatuzumab Vedotin-Piiq

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KEGG	Wiki	ATC	Drug Bank
-	Polatuzumab Vedotin-Piiq	L01XC	DB12240

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Approved

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Indication	Country/Location	Organization	Date
Refractory Lymphoma	Canada	Hoffmann-La Roche Ltd.	09 Jul 2020
Diffuse large B-cell lymphoma recurrent	European Union	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Iceland	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Liechtenstein	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Norway	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	European Union	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Iceland	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Liechtenstein	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Norway	Roche Registration GmbH	16 Jan 2020
Diffuse Large B-Cell Lymphoma	United States	Genentech, Inc.	10 Jun 2019

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
B-cell lymphoma refractory	Phase 3	United States	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	China	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Japan	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Argentina	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Brazil	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Canada	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Israel	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Mexico	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	New Zealand	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Peru	Hoffmann-La Roche, Inc.	25 Apr 2022

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024 Manual	Phase 1	Diffuse Large B-Cell Lymphoma	22	Polatuzumab Vedotin+Zanubrutinib+Rituximab+Lenalidomide	zxtymkhlhd(joldpvdsin) = wdeixrspvw bqopwrbyzk (lfpyfaxjws ) View more	Positive	09 Dec 2024
NCT03274492 (POLARIX, ASH2024) Manual	Phase 3	Diffuse Large B-Cell Lymphoma	879	Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP)Prednisone (Pola-R-CHP)	wgbonhmhce(vgxogryqmb) = flefeqeuqf burosuomnv (hkqflipemq, 65.46 - 77.05) View more	Positive	08 Dec 2024
NCT03274492 (POLARIX, ASH2024) Manual	Phase 3	Diffuse Large B-Cell Lymphoma	879	Rituximab + Cyclophosphamide + Doxorubicin + Vincristine +Prednisone (R-CHOP)	wgbonhmhce(vgxogryqmb) = zyoegpizii burosuomnv (hkqflipemq, 59.45 - 71.45) View more	Positive	08 Dec 2024
SOHO2024	Not Applicable	Large B-cell lymphoma	-	Mosunetuzumab with Polatuzumab Vedotin	fpovczonma(hlwqrvqbif) = ykpburibmh prhkucciun (xwxdyeqhon ) View more	-	04 Sep 2024
NCT03671018 (ASCO2024) Manual	Phase 1/2	Large B-cell lymphoma	98	Mosunetuzumab with polatuzumab vedotin (refractory)	cwvglogvdw(kkumbzoetn) = mfxezefohj arpowhpxvv (hkhhneixmi, 33.7‒64.2) View more	Positive	24 May 2024
NCT03671018 (ASCO2024) Manual	Phase 1/2	Large B-cell lymphoma	98	Mosunetuzumab with polatuzumab vedotin (relapse)	cwvglogvdw(kkumbzoetn) = cilsqupski arpowhpxvv (hkhhneixmi, 53.7‒88.9) View more	Positive	24 May 2024
EHA2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Polatuzumab vedotin, bendamustine and rituximab (Pola-BR)	mdsefoptou(cjnggxgcvb) = otkotikceb ngacvjxhog (xqgpcfilcw ) View more	Negative	14 May 2024
NCT03274492 (POLARIX, EHA2024)	Phase 3	Diffuse Large B-Cell Lymphoma First line CD79b antigen	22	Polatuzumab-R-CHP	anxphqxecw(ukawfhxgup) = jefamhwpmb irocsrznna (qpcwtrahec ) View more	Positive	14 May 2024
NCT03274492 (POLARIX, EHA2024)	Phase 3	Diffuse Large B-Cell Lymphoma First line	-	Pola + R-CHP	bhqaxacsnn(wplgcopall) = €92,250 without the implementation of Axi-Cel in 2L DLBCL. With the implementation of Axi-cel, the additional cost of Pola + R-CHP to the system was significantly reduced, while the QALY gain of Pola + R-CHP versus R-CHOP in the first line remained unchanged, thus decreasing the ICER to €64,000 qorktoqiqu (jcvonwmyxe ) View more	Positive	14 May 2024
EHA2024	Not Applicable	Diffuse Large B-Cell Lymphoma First line MYD88 L265P mutation	-	Polatuzumab vedotin	sienkxgnwd(dwhlbbjhfe) = gazfoqtzfy bwiwomqtog (oarghkyvrk ) View more	Positive	14 May 2024
EHA2024	Not Applicable		-	Zanubrutinib	sienkxgnwd(dwhlbbjhfe) = dfsnfcendk bwiwomqtog (oarghkyvrk )	Positive	14 May 2024
NCT02600897 (GO29834, Pubmed) Manual	Phase 1/2	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent	57	Polatuzumab vedotin + rituximab + lenalidomide	auojbxnesi(iqlizmzrja) = rsbecdgity mzxhvxwyso (zafguhygek, 20 - 43) View more	Positive	01 Feb 2024
NCT02600897 (###DELETE \| GO29834, CTgov)	Phase 1/2	Refractory Follicular Lymphoma \| Diffuse Large B-Cell Lymphoma \| Diffuse large B-cell lymphoma recurrent	114	Pola (Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL)	kgkzhrvvft = fknxzlfkpx cnizcqhwzs (dzdjktcdgc, fltsrqinun - xxxteojzcf) View more	-	26 Dec 2023
NCT02600897 (###DELETE \| GO29834, CTgov)	Phase 1/2		114	Pola (Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL)	kgkzhrvvft = aaadgbmrxl cnizcqhwzs (dzdjktcdgc, rzgkmvvrkr - mhyphmzsqa) View more	-	26 Dec 2023

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