Drugs / Mosunetuzumab
Mosunetuzumab
also known as
BTCT4465A · Lunsumio · Mosunetuzumab axgb · RG-7828 · RG-7828 (ANTI-CD20 & CD3) · RO-7030816
Monoclonal antibody targets MS4A1
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed follicular lymphoma, susceptibility to 1 milestone | |||||
| Filed | US (FDA) | Lunsumio | follicular lymphoma, susceptibility to | 2022-07-06 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio® (mosunetuzumab)” roche.com ↗ “today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab” gene.com ↗ |
| Filed non-Hodgkin lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | non-Hodgkin lymphoma | — | “Roche recently submitted the initial marketing authorisation application for mosunetuzumab to the European Medicines Agency” roche.com ↗ “Roche recently submitted the marketing authorisation application for mosunetuzumab to the European Medicines Agency.” roche.com ↗ “Roche recently submitted the marketing authorisation application for mosunetuzumab to the European Medicines Agency” roche.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Lunsumio | — | 2022-06-03 | europa.eu ↗ |
Trials 53
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06015880 | May 2024 → Jun 2027 expected | high grade B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05961696 | Jul → Oct 2023 | B-cell acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05464329 | Jan 2023 → Jan 2026 overdue | high grade B-cell lymphoma, large B-cell lymphoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05412290 | Dec 2022 → Jan 2027 expected | high grade B-cell lymphoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05169515 | Oct 2022 → Sep 2029 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT04970901 | Jun 2022 → Mar 2027 expected | B-cell non-Hodgkin lymphoma | ADC Therapeutics S.A. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05091424 | Mar 2022 → Feb 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT05155345 | Jan 2022 → Dec 2024 | systemic lupus erythematosus | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04313608 | Jun 2020 → Oct 2021 | B-cell neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/210 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07052695 | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06634589 | Nov 2024 → Dec 2028 expected | B-cell non-Hodgkin lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06249191 | Jun 2024 → Dec 2026 expected | high grade B-cell lymphoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06090539 | Dec 2023 → Oct 2027 expected | non-Hodgkin lymphoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05315713 | May 2022 → Jul 2023 | follicular lymphoma | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04246086 | Aug 2020 → Sep 2030 expected | follicular lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03677154 | May 2019 → Aug 2025 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03677141 | Mar 2019 → Oct 2023 | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03671018 | Sep 2018 → Jan 2024 overdue | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 1/2 | NCT02500407 | Sep 2015 → May 2024 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | Mixed |
| Phase 229 trials | ||||||
| Phase 2 | NCT07548450 | Nov 2026 → Nov 2034 expected | Waldenstrom macroglobulinemia | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07638722 | Oct 2026 → Apr 2034 expected | MALT lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07566364 | Oct 2026 → Oct 2028 expected | lymphoid leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06594939 | Jun 2026 → Jun 2028 expected | diffuse large B-cell lymphoma | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07598396 | May 2026 → Feb 2028 expected | lupus nephritis, systemic lupus erythematosus | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07555470 | Apr 2026 → Dec 2029 expected | follicular lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06948786 | Nov 2025 → Jul 2031 expected | follicular lymphoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT07191249 | Oct 2025 → Apr 2028 expected | follicular lymphoma | Tel-Aviv Sourasky Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06828991 | Sep 2025 → Apr 2029 expected | diffuse large B-cell lymphoma | Danielle Wallace | Recruiting | No outcome recorded |
| Phase 2 | NCT07031700 | Jul 2025 → Jun 2027 expected | B-cell neoplasm | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06563505 | Dec 2024 → Dec 2026 expected | lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06569680 | Nov 2024 → Dec 2030 expected | MALT lymphoma | Izidore Lossos, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06492837 | Oct 2024 → Sep 2028 expected | follicular lymphoma | Fondazione Italiana Linfomi - ETS | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06453044 | Sep 2024 → Mar 2028 expected | B-cell non-Hodgkin lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06442475 | Aug 2024 → Aug 2026 overdue | marginal zone lymphoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06926205 | May 2024 → May 2028 expected | Richter transformation | GELLC (Grupo Español de Leucemia Linfocítica Crónica) | Recruiting | No outcome recorded |
| Phase 2 | NCT05886036 | Jan 2024 → Oct 2026 expected | nodular lymphocyte predominant Hodgkin lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05672251 | Jan 2024 → Aug 2029 expected | Richter transformation, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05994235 | Nov 2023 → Oct 2033 expected | follicular lymphoma | Weill Medical College of Cornell University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05849857 | Sep 2023 → Jun 2027 expected | follicular lymphoma | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05633615 | Jun 2023 → Jun 2030 expected | primary mediastinal large B-cell lymphoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT05615636 | Apr 2023 → Aug 2027 expected | B-cell non-Hodgkin lymphoma, Hodgkins lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05260957 | Dec 2022 → Dec 2026 expected | non-Hodgkin lymphoma | Lazaros Lekakis | Recruiting | No outcome recorded |
| Phase 2 | NCT05410418 | Oct 2022 → Sep 2025 overdue | follicular lymphoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04792502 | Jul 2022 → Aug 2027 expected | follicular lymphoma, marginal zone lymphoma | Brown University | Recruiting | No outcome recorded |
| Phase 2 | NCT05389293 | May 2022 → Dec 2026 expected | follicular lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05169658 | Mar 2022 → Apr 2025 | MALT lymphoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT05207670 | Feb 2022 → Jul 2027 expected | non-Hodgkin lymphoma | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04889716 | Nov 2021 → Dec 2027 expected | diffuse large B-cell lymphoma, large B-cell lymphoma | Abramson Cancer Center at Penn Medicine | Active not recruiting | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT06337318 | Oct 2024 → Mar 2032 expected | follicular lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT06284122 | Jun 2024 → Nov 2028 expected | follicular lymphoma | The Lymphoma Academic Research Organisation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06006117 | Sep 2023 → Sep 2027 expected | marginal zone lymphoma | The Lymphoma Academic Research Organisation | Recruiting | No outcome recorded |
| Phase 3 | NCT05171647 | Apr 2022 → Feb 2025 overdue | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04712097 | Oct 2021 → Jun 2026 overdue | B-cell neoplasm | Hoffmann-La Roche | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2026-09-17 | Hoffmann-La Roche | Results Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study roche.com ↗
Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). |
| 2026-09-16 | Genentech, Inc. | Results Genentech’s Lunsumio-Based Regimen Significantly Improves Progression-Free Survival in Follicular Lymphoma in Phase III CELESTIMO Study gene.com ↗
Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival. |
| 2026-06-18 | Hoffmann-La Roche | Regulatory FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2026-06-17 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2026-03-23 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Lunsumio and Polivy Combination Therapy for Additional Indication of Relapsed or Refractory Large B-cell Lymphoma chugai-pharm.co.jp ↗
This marks the first approval in the world for the combination therapy of Lunsumio and Polivy for this indication. |
| 2025-12-22 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma roche.com ↗
Based on the study results, Lunsumio VELO is approved under accelerated approval. |
| 2025-12-21 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma gene.com ↗
Based on the study results, Lunsumio VELO is approved under accelerated approval. |
| 2025-12-08 | Hoffmann-La Roche | Results Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas roche.com ↗
These results indicate the potential of this combination to deliver meaningful outcomes earlier in the disease course.1 |
| 2025-12-08 | Genentech, Inc. | Results Genentech Presents Lunsumio Data Showing Potential Across Earlier Treatment Lines in Indolent and Aggressive Lymphomas gene.com ↗
Long term follow-up data from the Phase Ib/II GO40516 study demonstrated sustained improvements in patients treated with investigational SC Lunsumio in combination with Polivy compared to those treated with Rituxan® (rituximab) and Polivy in people with 2L+ LBCL. |
| 2025-12-01 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASH 2025 Showcase Potential of Hematology Pipeline and Build Momentum for Next Generation Portfolio bms.com ↗
Mosunetuzumab (mosun) or glofitamab (glofit) in combination with golcadomide (Golca) demonstrated a manageable safety profile and encouraging efficacy in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (partner study) |
| 2025-11-19 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma roche.com ↗ |
| 2025-11-03 | Hoffmann-La Roche | Results Roche to present new data from its broad and innovative haematology portfolio at ASH 2025 roche.com ↗
Preliminary data from the US extension arm of the phase III CELESTIMO study investigating Lunsumio plus lenalidomide, in people with second-line or later (2L+) relapsed or refractory (R/R) follicular lymphoma (FL), support its potential as an effective and well-tolerated outpatient treatment option. |
| 2025-11-03 | Genentech, Inc. | Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗
Preliminary data from the U.S. extension arm of the Phase III CELESTIMO study investigating Lunsumio plus lenalidomide, in people with second-line or later (2L+) relapsed or refractory (R/R) follicular lymphoma, support its potential as an effective and well-tolerated outpatient treatment option. |
| 2025-09-19 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2025-06-20 | Hoffmann-La Roche | Results Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNMO [NCT05171647] study showing Lunsumio® (mosunetuzumab) administered subcutaneously in combination with Polivy® (polatuzumab vedotin) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to MabThera®/Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. |
| 2025-06-20 | Genentech, Inc. | Results Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2024-12-10 | Hoffmann-La Roche | Results New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma roche.com ↗
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 dosing1,2,3 |
| 2024-12-09 | Genentech, Inc. | Results New and Updated Data for Genentech’s Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma gene.com ↗ |
| 2024-11-05 | Hoffmann-La Roche | Results Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024 roche.com ↗
Extended follow-up data of up to four years from the pivotal GO29781 study of Lunsumio (abstract #4407) and NP30179 study of Columvi (abstract #865) show long-lasting remissions and immune system recovery after the end of treatment, supporting the use of fixed-duration bispecific antibodies for third line or later (3L+) follicular lymphoma (FL) and DLBCL respectively.2,3 |
| 2024-11-05 | Genentech, Inc. | Results Genentech to Present New and Encouraging Long-term Follow-up Data Across Broad Hematology Portfolio at ASH 2024 gene.com ↗
show long-lasting remissions and immune system recovery after the end of treatment |
| 2024-04-04 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma adctherapeutics.com ↗
Additionally, after the first investigator assessment, evidence of anti-tumor activity was observed among the majority of patients, with mixed histologies including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). |
| 2024-01-04 | ADC Therapeutics S.A. | Results ADC Therapeutics Provides Business Updates adctherapeutics.com ↗
We are also encouraged to see positive initial signals in the LOTIS-7 trial of ZYNLONTA in combination with bispecifics as well as early signs of antitumor activity in the Phase 1b trial of ADCT-601. |
| 2023-12-11 | Hoffmann-La Roche | Results New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma roche.com ↗
Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas. |
| 2023-12-10 | Genentech, Inc. | Results New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma gene.com ↗
Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab-gxbm) and Lunsumio® (mosunetuzumab-axgb), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas. |
| 2022-12-23 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma roche.com ↗
Lunsumio is now the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA to treat the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma |
| 2022-12-22 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2022-12-12 | Hoffmann-La Roche | Results Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma roche.com ↗
27-month follow-up data showed Lunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response3 |
| 2022-12-12 | Genentech, Inc. | Results Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma gene.com ↗
27-month follow-up data showed mosunetuzumab continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response |
| 2022-11-03 | Hoffmann-La Roche | Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗
Subcutaneous (SC) Mosunetuzumab is Active with a Manageable Safety Profile in Patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin Lymphoma (B-NHL): Updated Results from a Phase I/II Study |
| 2022-11-03 | Genentech, Inc. | Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗
Subcutaneous (SC) Mosunetuzumab is Active with a Manageable Safety Profile in Patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin Lymphoma (B-NHL): Updated Results from a Phase I/II Study |
| 2022-07-06 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche’s Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio® (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. |
| 2022-07-05 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Mosunetuzumab for People with Relapsed or Refractory Follicular Lymphoma gene.com ↗
FDA Grants Priority Review to Genentech’s Mosunetuzumab for People with Relapsed or Refractory Follicular Lymphoma |
| 2022-06-08 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2022-04-22 | Hoffmann-La Roche | Regulatory CHMP recommends EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2021-12-11 | Hoffmann-La Roche | Results Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab roche.com ↗
Pivotal results from the phase I/II GO29781 study demonstrated that mosunetuzumab induces durable complete responses lasting at least 18 months in heavily pretreated patients with R/R FL who have received two or more prior therapies, with a 60.0% complete response (CR) rate and a median progression-free survival of 17.9 months (95% CI: 10.1-not evaluable). |
| 2021-12-11 | Genentech, Inc. | Results Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab gene.com ↗
Results to be presented for the first time show mosunetuzumab induces high and durable complete response rates in people with follicular lymphoma who have received two or more prior therapies |
| 2021-11-23 | Hoffmann-La Roche | Results Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders roche.com ↗
Pivotal data on mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, showed high response rates in relapsed or refractory follicular lymphoma (FL)2 |
| 2021-11-23 | Genentech, Inc. | Results Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders gene.com ↗
Pivotal data on mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, showed high response rates in relapsed or refractory follicular lymphoma |
| 2021-06-04 | Hoffmann-La Roche | Results Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma roche.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin lymphoma in early studies |
| 2021-06-04 | Genentech, Inc. | Results Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin’s Lymphoma gene.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin’s lymphoma in early studies |
| 2020-12-08 | Hoffmann-La Roche | Results Roche presents new data from its bispecific antibody portfolio across a range of blood cancers roche.com ↗ |
| 2020-11-05 | Hoffmann-La Roche | Results Roche to present new data across 16 blood disorders at the American Society of Hematology 2020 Annual Meeting roche.com ↗
Mosunetuzumab Shows Promising Efficacy in Patients with Multiply Relapsed Follicular Lymphoma: Updated Clinical Experience from |
| 2020-11-05 | Genentech, Inc. | Results Genentech to Present New Data Across 16 Blood Disorders at the American Society of Hematology 2020 Annual Meeting gene.com ↗
Mosunetuzumab Shows Promising Efficacy in Patients with Multiply Relapsed Follicular Lymphoma |
| 2019-12-07 | Genentech, Inc. | Results Genentech Announces New Data on Novel CD20-CD3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas gene.com ↗
Mosunetuzumab data to be presented at the American Society of Hematology 2019 Annual Meeting Plenary Scientific Session demonstrate durable complete responses in people with relapsed or refractory non-Hodgkin’s lymphoma |
| 2019-11-06 | Hoffmann-La Roche | Results Roche to present new data highlighting breadth of haematology portfolio and pipeline at the American Society of Hematology 2019 Annual Meeting roche.com ↗
Mosunetuzumab Induces Complete Remissions in Poor Prognosis Non-Hodgkin Lymphoma Patients, Including Those Who Are Resistant to or Relapsing After Chimeric Antigen Receptor T-Cell (CAR-T) Therapies, and Is Active in Treatment through Multiple Lines |
| 2019-11-06 | Genentech, Inc. | Results Genentech to Present New Data Highlighting Breadth of Hematology Portfolio and Pipeline at the American Society of Hematology 2019 Annual Meeting gene.com ↗
Mosunetuzumab Induces Complete Remissions in Poor Prognosis Non-Hodgkin Lymphoma Patients, Including Those Who Are Resistant to or Relapsing After Chimeric Antigen Receptor T-Cell (CAR-T) Therapies, and Is Active in Treatment through Multiple Lines |
All press releases naming this drug 50 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mosunetuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02500407 ↗ |
| Known as | BTCT4465A | “Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in...” NCT03677154 ↗2“This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab” NCT02500407 ↗ “Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin” NCT03677141 ↗ |
| Known as | Lunsumio | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297788 ↗ |
| Known as | Mosunetuzumab axgb | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297788 ↗ |
| Known as | RG-7828 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297788 ↗ |
| Known as | RG-7828 (ANTI-CD20 & CD3) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297788 ↗ |
| Known as | RO-7030816 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297788 ↗ |
| Action | Deplete | “Mosunetuzumab, a CD20 × CD3 T-cell-engaging bispecific antibody, redirects T cells to eliminate malignant B cells.” PMID 40279333 ↗ May 2025 |
| Modality | Monoclonal antibody | “Mosunetuzumab and obinutuzumab are monoclonal antibodies” NCT05169658 ↗ |
| Route | Intravenous | “Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.” NCT02500407 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL4297788 ↗ |