RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 31212L

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Sequence Code 616715439H

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Sequence Code 616715440L

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Sequence Code 651228354H

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Clinical Trials associated with Mosunetuzumab

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

NCT06828991

/ Not yet recruitingPhase 2IIT

CtDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients with Untreated DLBCL

Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important. The ability to measure small amounts of persistent lymphoma (circulating tumor DNA or ctDNA) might allow the investigators to risk stratify patients. If older patients have detectable ctDNA in the blood at the end of six cycles of polatuzumab vedotin, rituximab and dose-attentuated CHP chemotherapy, patients will receive a bispecific antibody called mosunetuzumab. The investigators hypothesize this will result in "clearing" the ctDNA from the blood and result in better disease control and outcomes for patients. The study will also measure the safety of this regimen and the impact on the function of these older patients utilizing a tool called the geriatric assessment.

Start Date01 Apr 2025

Sponsor / Collaborator

University of Rochester

[+3]

NCT06563505

/ RecruitingPhase 2IIT

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Start Date11 Dec 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Mosunetuzumab

100 Translational Medicine associated with Mosunetuzumab

100 Patents (Medical) associated with Mosunetuzumab

Literatures (Medical) associated with Mosunetuzumab

01 Mar 2025·Journal of Cancer Policy

Trials that treat what should be observed: SWOG 2308, a study of mosunetuzumab-axgb in asymptomatic low tumor burden follicular lymphoma

Article

Author: Prasad, Vinay ; Kim, Myung Sun

S2308 is a study comparing rituximab, which is not the standard of care, to.mosunetuzumab-axgb, a first-in-class CD20-directed CD3 T-cell engager with.unknown long term side effects, in a heterogeneous patient population in which a fifth.of patients do not need treatment for at least 10 years. The treatment of asymptomatic.low tumor burden follicular lymphoma is watchful waiting and no treatment has.demonstrated improvement in OS after long term follow up. Beyond the limitations of.the study design, this study would be the basis of regulatory approval and cooperative.groups receiving federal funding should not be running this trial. Study sites are US based and mostly include community oncology practices, risking inclusion of very low.risk patients that are most likely to be harmed by any treatment.

25 Feb 2025·Blood Advances

Impact of prior CAR T-cell therapy on mosunetuzumab efficacy in patients with relapsed or refractory B-cell lymphomas

Article

Author: Wu, Mei ; Shadman, Mazyar ; Matasar, Matthew J. ; Bartlett, Nancy L. ; Napier, Ellen B. ; Goy, Andre ; Schuster, Stephen J. ; Flinn, Ian W. ; Kumar, Anita ; Fraietta, Joseph A. ; Budde, Lihua E. ; Fay, Keith ; Bosch, Francesc ; Chong, Emeline R. ; Lundberg, Rachel K. ; Chong, Elise A. ; Yin, Shen ; Wei, Michael C. ; Nastoupil, Loretta J. ; Penuel, Elicia

Abstract:

Mosunetuzumab and other CD20/CD3 bispecific antibodies (BsAbs) have efficacy in B-cell lymphomas relapsing after or refractory to CD19-directed chimeric antigen receptor (CAR)–modified T cells (CAR-T). The optimal timing of BsAbs and biomarkers of BsAb response after CAR-T are unknown. We addressed these questions using clinical data and blood samples from patients previously treated with CAR-T and subsequently treated on a phase 1/2 study of mosunetuzumab. Thirty patients had paired samples at baseline and after 1 cycle of mosunetuzumab. The median time from CAR-T to mosunetuzumab was significantly longer for responding than for nonresponding patients (P = .006, unadjusted for multiple comparisons). Most patients (20/30) did not receive intervening therapy between CAR-T administration and mosunetuzumab. The remainder of patients received 1 intervening therapy after a protocol-mandated drug washout. After mosunetuzumab, responding patients had higher lymphocytes (995 vs 400 cells per μL; P = .02) and greater increases in CD4 and CD8 cells (median change, 73 vs –90 cells per μL [P = .005] and 243 vs –103 cells per μL [P = .004], respectively). Additionally, responding patients had an increase in activated CD8 cells (median fold change, 1.7; P = .02). Nonresponders had a relative decrease in CAR transgene levels (n = 16; P = .04). This is, to our knowledge, the first study to assess changes in lymphocytes, T cells, and CAR transgene levels in patients treated with BsAbs after CAR-T. These findings suggest an interaction between prior CAR-T and BsAb outcomes and have implications for optimal timing of BsAb after CAR-T. The trial was registered at www.ClinicalTrials.gov as #NCT02500407.

13 Feb 2025·BLOOD

Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

Article

Author: Shadman, Mazyar ; Schuster, Stephen J. ; Assouline, Sarit E. ; Bolen, Christopher R. ; Ku, Matthew ; Bartlett, Nancy L. ; To, Iris ; Kwan, Antonia ; Kuruvilla, John ; Budde, Lihua E. ; Kaufman, Derrick ; Penuel, Elicia ; Dietrich, Sascha ; Cheah, Chan Yoon ; Fay, Keith ; Yin, Shen ; Sehn, Laurie H. ; Giri, Pratyush ; Wei, Michael C. ; Nastoupil, Loretta J. ; Matasar, Matthew J.

Abstract:

Mosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.clinicaltrials.gov as #NCT02500407.

133

News (Medical) associated with Mosunetuzumab

26 Feb 2025

·endpts.com

After rejection, Regeneron seeks accelerated approval of bispecific for only one of two types of lymphoma

Regeneron is now expecting an accelerated approval decision this summer on its T cell engager for one form of lymphoma, while it’s giving up on accelerated approval for a different form of the disease. The FDA last March rejected the biotech’s application for odronextamab over its confirmatory trial enrollment status in both follicular lymphoma and diffuse large B cell lymphoma (DLBCL). Regeneron said Wednesday that the FDA set a decision deadline of July 30 for odronextamab in follicular lymphoma that has returned or is not responding to treatment. The drug would be for patients who have tried at least two previous lines of systemic therapy. However, Regeneron is no longer asking for accelerated approval in DLBCL. “Due to competitor developments, we no longer believe odronextamab in R/R DLBCL has an accelerated approval path and therefore, we plan to seek full approval pending data from ongoing Phase 3 studies,” a Regeneron spokesperson told Endpoints News via email. In DLBCL, Roche announced in December that a Phase 3 study showed its T cell engager Columvi plus chemotherapy led to a statistically significant improvement in overall survival, and it’s expecting an FDA decision to update the drug’s label in July. In order to ask for approval now, Regeneron would likely also need to show a survival benefit in a late-stage study. That’s likely to delay Regeneron’s US expansion of odronextamab into DLBCL, the more common form of lymphoma between the two, by years. Regeneron’s Phase 3 trial in DLBCL is expected to wrap up in 2028, according to a federal clinical trials database . Odronextamab is a bispecific antibody that targets two proteins found on cells: CD20 on malignant B cells, and CD3 on T cells. By bridging the two, the hope is that the therapy will lead the immune system to kill the cancer cells. If approved, odronextamab would be the fourth CD20xCD3 bispecific to make it to market in the US. AbbVie and Genmab market Epkinly, while Roche subsidiary Genentech markets two CD20xCD3 bispecifics in Lunsumio and Columvi. Regeneron said Wednesday that the FDA accepted its application for follicular lymphoma after achieving “an FDA-mandated enrollment target” for its confirmatory trial, though it declined to specify what that target was. The biotech noted that was the “sole approvability issue” raised by the FDA in its last submission . Regeneron said in February that the study was over 40% enrolled, and according to a federal clinical trials database, the Phase 3 confirmatory study is expected to enroll 478 patients. The FDA has been calling for faster confirmatory trials, suggesting they should be “well underway” at the time of an accelerated approval. Regeneron is asking for approval for follicular lymphoma based on clinical trial data that showed 80% of patients responded to treatment, with 74% seeing all signs of their cancer disappear. In the EU, odronextamab was approved in August and is marketed as Ordspono for both indications after two-plus lines of systemic therapy. The FDA last week set a July 10 decision deadline for Regeneron’s multiple myeloma bispecific linvoseltamab, which it previously rejected over manufacturing issues . Editor’s note: This story was corrected to reflect that the PDUFA date for linvoseltamab is July 10, not August 22.

Phase 3Accelerated ApprovalDrug Approval

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

30 Jan 2025

·www.chugai-pharm.co.jp

Chugai Announces Consolidated 2024 Full Year Results and Forecasts for 2025

Record high core revenue, core operating profit and core net income for the fiscal year 2024 at ¥1,170.6 billion (+5.3%), ¥556.1 billion (+23.4%) and ¥397.1 billion (+19.0%) respectively (all changes year-on-year [YoY]) Steady progress in R&D activities of in-house projects for both early and late-stage development, with new investment activities In early-stage development, NXT007 and AMY109 proceeded to Phase II clinical trials, and several projects started clinical trials. BRY10, a project applied with Chugai’s AI-assisted drug discovery technology, entered the clinical trial stage PiaSky, Alecensa, and NEMLUVIO received global approval In addition, Chugai Venture Fund made three investments Planned 2024 year-end dividends are ¥57 per share (annual dividends for the fiscal year: ¥98 per share) Core revenue and core operating profit in 2025 are expected to reach record highs of ¥1,190.0 billion (+1.7%, YoY) and ¥570.0 billion (+2.5%, YoY), respectively Annual dividend forecast for 2025 is ¥250 per share, including 100th Anniversary Special Dividends of ¥150 per share TOKYO, January 30, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its consolidated financial results for the fiscal year ended December 31, 2024, and forecasts for the fiscal year ending December 31, 2025. “In 2024, Chugai marked record high revenue, operating profit, and net income. Despite the decrease in domestic sales due to impact of the completion of government supply of Ronapreve® for COVID-19, NHI drug price revisions and penetration of biosimilars, the greatly increased export of Hemlibra® to Roche and other factors contributed to the growth. In R&D, this year saw many achievements of global approvals for our in-house products. PiaSky® obtained initial approval for the treatment of paroxysmal nocturnal hemoglobinuria, and Alecensa® obtained approval for the additional indication of adjuvant treatment of non-small cell lung cancer in Japan, the United States, Europe and China. In addition, NEMLUVIO®, out-licensed to Galderma, obtained approval for the treatment of prurigo nodularis and atopic dermatitis in the United States. In early development of in-house projects, NXT007 and AMY109 proceeded to phase II clinical trials, and several projects including GYM329, DONQ52 and RAY121, have started new clinical trials. Furthermore, BRY10 marked the first project to enter the clinical development stage, which utilized Chugai’s proprietary AI-based antibody drug discovery support technology, MALEXA®. Chugai Venture Fund, which became fully operational in 2024, is implementing multiple investments that are expected to strengthen our company’s technology and drug discovery capabilities. 2025 marks the 100-year anniversary of the company’s founding. With the aspiration of ‘Creating drugs that benefit the world’ which has been consistently carried from the time of our founding, and by focusing on our unique science and technology capabilities and creating our unique innovation, Chugai will strive in the next 100 years, to continue to expand the benefit of medical community and human health around the world for the sake of patients,” said Dr. Osamu Okuda, Chugai’s President and CEO. Chugai reported that revenue for the fiscal year ended December 2024 totaled ¥1,170.6 billion (+ ¥59.2 billion, +5.3%, YoY). Domestic sales were ¥461.1 billion (- ¥96.9 billion, -17.4%, YoY). In the oncology field, although our new product Phesgo® performed well, products including our mainstay product Avastin® were affected by NHI drug price revisions and biosimilars. Also, sales of Perjeta® and Herceptin® fell along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients, resulting in a decrease by 4.8% compared to the previous year. In the specialty field, sales decreased by 28.3% compared with previous year, mainly due to the completion of supply of Ronapreve to the government, despite that our new product Vabysmo® grew and our mainstay products Hemlibra and Actemra® performed well. Overseas sales were ¥536.8 billion (+ ¥120.3 billion, +28.9%, YoY), driven by a substantial increase in exports of Hemlibra to Roche. Other revenue increased by 26.2% mainly due to increase in one-time income, etc., in addition to the increase in income related to Hemlibra. Cost to sales ratio improved by 8.4 percentage points year-on-year to 33.9%, mainly due to a change in the product mix. Research and development expenses amounted to ¥176.9 billion (+8.7%, YoY) due to investments into drug discovery and early development, and the progress of development projects. Selling, general and administration expenses were comparable to the previous year, amounting ¥102.2 billion (+0.2%, YoY). For other operating income (expense), an income of ¥2.7 billion was recorded, mainly due to the recognition of income from disposal of product rights. As a result, Core operating profit totaled ¥556.1 billion (+ ¥105.4 billion, +23.4%, YoY), which marked the first time exceeding ¥500.0 billion, and Core net income increased to ¥397.1 billion (+ ¥63.5 billion, +19.0%, YoY). Reflecting the favorable results and based on our principles of “a stable allocation of profit” and “aiming for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS,” year-end dividends for the fiscal year ended December 31, 2024 are planned to be ¥57 per share. As a result, the annual dividend per share will be ¥98 per share, and the Core dividend payout ratio is 40.6% (an average of 40.3% for the past five years). Regarding research and development, Chugai made good progress in both early and late-stage development toward achieving TOP I 2030. Chugai made important progress in both in-house and in-licensed products, and in addition, through new investments, Chugai strengthened its efforts to create innovative solutions. For in-house projects that will drive mid to long-term growth, NXT007 and AMY109, both applying Chugai’s proprietary antibody engineering technologies, have entered Phase II clinical trials. Additionally, RAY121 (for autoimmune diseases), BRY10 (for chronic diseases), GYM329 (for neurological disorders and obesity), and DONQ52 (for celiac disease) each have entered new clinical trials. In late-stage projects, PiaSky, a treatment for paroxysmal nocturnal hemoglobinuria, was launched in Japan and approved in the U.S., Europe, and China. Alecensa was approved for expanded indication as post-operative adjuvant therapy for ALK-positive non-small cell lung cancer in Japan, the U.S., Europe, China and Taiwan. In-house products out-licensed to third parties excluding Roche also progressed steadily. NEMLUVIO (nemolizumab), being developed overseas by Galderma, has advanced significantly as a global product, having been approved for prurigo nodularis and moderate-to-severe atopic dermatitis in the U.S. and having been recommended for approval for the same indications by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Avutometinib, out-licensed to Verastem Oncology, has been accepted for review of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for accelerated approval in KRAS-mutant recurrent low-grade serous ovarian cancer and has been granted Priority Review. As for projects in-licensed from Roche, Lunsumio® has received regulatory approval in Japan for relapsed or refractory follicular lymphoma. Elevidys (SRP-9001), Chugai’s first gene therapy product, has been filed with a regulatory application in Japan for Duchenne muscular dystrophy. Vabysmo and Evrysdi® received approvals for expanded indications, and Tecentriq® filed an application for expanded indication. In 2024, to further accelerate our drug discovery engine through open innovation, Chugai Venture Fund, LLC made investments in Leal Therapeutics, HYKU Biosciences, and one other company, strengthening Chugai’s efforts in creating innovative solutions. In 2025, Core revenues, Core operating profit, and Core net income are expected to be ¥1,190.0 billion (+ ¥19.4 billion, +1.7%, YoY), ¥570.0 billion (+ ¥13.9 billion, +2.5%, YoY), and ¥410.0 billion (+ ¥12.9 billion, +3.2%, YoY), resulting in an increase in both revenues and profits. Sales are expected to increase in Japan and overseas, totaling ¥1,018.0 billion (+ ¥20.1 billion, +2.0%, YoY). Domestic sales are expected to be ¥462.5 billion (+ ¥1.4 billion, +0.3%, YoY), including increase in volume of new product Phesgo, PiaSky and our mainstay products. Overseas sales are expected to be ¥555.5 billion (+ ¥18.7 billion, +3.5%, YoY) due to growth in sales of Hemlibra, Alecensa and NEMLUVIO, despite decrease in Actemra. Other revenues are expected to be ¥172.0 billion (- ¥0.7 billion, -0.4%, YoY). Royalty and profit-sharing income are forecasted to increase to ¥165.7 billion (+ ¥18.3 billion, +12.4%, YoY), due to an increase in income related to Hemlibra, despite a decrease in income related to Actemra. On the other hand, other operating income is expected to decrease to ¥6.3 billion (- ¥19.0 billion, -75.1%, YoY), due to a decrease in one time income. For the following fiscal year ending December 31, 2025, Chugai expects annual dividends of ¥100 in regular dividends (interim dividends of ¥50 and year-end dividends of ¥50) and ¥150 as special dividends for the company's 100th anniversary (interim dividends of ¥75 and year-end dividends of ¥75) for a total of ¥250 per share. As a result, the Core dividend payout ratio for 2025 is expected to be 100.0% (54.1% on a five-year average basis). [2024 full year results] [Sales breakdown] [Oncology field (Domestic) Top5-selling medicines] +2.3% [Specialty field (Domestic) Top5-selling medicines plus Ronapreve] *Ronapreve has not been listed in the National Health Insurance (NHI) price list. [2025 full year forecast] [Progress in R&D activities from Oct 26th, 2024 to Jan 30th, 2025] About Core results Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders. Trademarks used or mentioned in this release are protected by law. [PDF 1.3MB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Hideki Sato Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back

Drug ApprovalPhase 2Financial Statement

100 Deals associated with Mosunetuzumab

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KEGG	Wiki	ATC	Drug Bank
D11463	-	-	DB15434

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Follicular Lymphoma	European Union	Roche Registration GmbH	03 Jun 2022
Follicular Lymphoma	Iceland	Roche Registration GmbH	03 Jun 2022
Follicular Lymphoma	Liechtenstein	Roche Registration GmbH	03 Jun 2022
Follicular Lymphoma	Norway	Roche Registration GmbH	03 Jun 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Large B-cell lymphoma	Phase 3	Switzerland	Roche Holding AG	23 May 2023
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	United States	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	China	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Japan	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Argentina	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Brazil	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Canada	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Israel	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Mexico	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	New Zealand	Hoffmann-La Roche, Inc.	25 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03677141 (CTgov)	Phase 1/2	B-Cell Lymphoma \| Diffuse Large B-Cell Lymphoma	117	CHP-Pola+Mosunetuzumab (Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized))	evdahymkjw = ioygxzislf izfeyltlvw (qosmnagfhw, azqkdjrvsu - lcmnjhvset) View more	-	25 Mar 2025
NCT03677141 (CTgov)	Phase 1/2	B-Cell Lymphoma \| Diffuse Large B-Cell Lymphoma	117	CHP-Pola+Rituximab (Arm 2: Phase II Rituximab + CHP-Pola (Randomized))	evdahymkjw = cykcjllinb izfeyltlvw (qosmnagfhw, zdonrjluna - lyqswqfdtx) View more	-	25 Mar 2025
ASH2024	Not Applicable	Refractory Follicular Lymphoma	-	Mosunetuzumab	qrihwbcmra(uqofunqrdj) = B-cell recovery to detectable levels was observed after a median of 19.0 months (95% CI: 12.8-25.1); immunoglobulin M recovery to the lower limit of normal was observed after a median of 40.7 months (95% CI: 36.1-NE) heduyccqds (dpmbtdhztr ) View more	-	09 Dec 2024
NCT05207670 (Morningsun, ASH2024)	Phase 2	Follicular Lymphoma First line CD20 \| CD3	65	Mosunetuzumab SC	gmhctfeafz(lgtqjhjjok) = CRS by ASTCT occurred in 30 pts (46.9%; Gr 1, 39.1%; Gr 2, 7.8%) urgijqbdsb (jvseipokqk ) View more	Positive	08 Dec 2024
ASH2024 Manual	Phase 2	Mantle-Cell Lymphoma	25	Mosunetuzumab	mpzbnyzgne(uqmswvcskb) = The most common adverse events (AEs) were CRS (52%), fatigue (36%), and pyrexia (36%). CRS events were predominantly Grade (Gr) 1/2 (48%); Gr 3 CRS occurred in 1 pt; no Gr ≥4 CRS events were reported. kgfoggjxmi (adbdyfezkr ) View more	Positive	07 Dec 2024
ASH2024	Not Applicable	Follicular Lymphoma	-	Mosunetuzumab SC	ybtiwzglrn(tnqszuvnaj) = cytokine release syndrome (CRS; 30%) brqdunopcc (dknjmdzita ) View more	-	07 Dec 2024
NCT05315713 (CTgov)	Phase 1/2	Follicular Lymphoma \| B-cell lymphoma refractory	8	Mosunetuzumab SC+tocilizumab+Tiragolumab	ejagelmqlr = jhwkcnzbbn gvnpdswfnm (svuxgdsbyl, feclsspslj - fehvwjtdfh) View more	-	04 Oct 2024
SOHO2024	Not Applicable	Large B-cell lymphoma	-	Mosunetuzumab with Polatuzumab Vedotin	xoyrwkqxyu(lglhgasgwv) = rzihutsztn xgeqgjfhcv (vdfiblzxpk ) View more	-	04 Sep 2024
SOHO2024	Not Applicable	Refractory Follicular Lymphoma	-	Mosunetuzumab	utylugxarw(pcsbipthpv) = CRS events occurred in 44.4% of patients (Grade 3/4, 2.2%); all resolved ylguutkeky (kfjhfpifdw ) View more	-	04 Sep 2024
NCT03671018 (ASCO2024) Manual	Phase 1/2	Large B-cell lymphoma	98	Mosunetuzumab with polatuzumab vedotin (refractory)	ffihwnrkwq(kzisvwtszw) = ihmzsctypc jgkryvryus (lkxrggkuar, 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)	ffihwnrkwq(kzisvwtszw) = tdhelpleav jgkryvryus (lkxrggkuar, 53.7‒88.9) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Non-Hodgkin Lymphoma First line CD20 \| CD3	124	Mosunetuzumab monotherapy	gwoljvnwgy(csngxqfgtm) = common adverse effects given in the table auqwbhrbim (muvwmjsjpd ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Non-Hodgkin Lymphoma First line CD20 \| CD3	124	Mosunetuzumab + CHOP		Positive	24 May 2024

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