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 · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Lunsumio | — | 2022-06-03 | europa.eu ↗ |
Trials 53 · a red edge is where a trial was stopped
| 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| Phase 1 | NCT05961696 | Jul → Oct 2023 | B-cell acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| 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 | ||||||
| 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 neoplasm | 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 |
| 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 | No outcome recorded |
| Phase 1/2 | NCT03671018 | Sep 2018 → Jan 2024 overdue | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02500407 | Sep 2015 → May 2024 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | No outcome recorded |
| Phase 229 trials | ||||||
| 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 | NCT07548450 | Jun 2026 → Jun 2034 expected | Waldenstrom macroglobulinemia | University of Utah | 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 | 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 → Mar 2027 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 | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| 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 | 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 | No outcome recorded |
| Phase 3 | NCT04712097 | Oct 2021 → Jun 2026 overdue | B-cell neoplasm | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Roche Global Development | 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 ↗ |
| 2025-12-22 | Roche Global Development | FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma roche.com ↗ |
| 2025-12-08 | Roche Global Development | Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas roche.com ↗ |
| 2025-11-19 | Roche Global Development | European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma roche.com ↗ |
| 2025-09-19 | Roche Global Development | CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2025-06-20 | Roche Global Development | Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2024-12-10 | Roche Global Development | 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 ↗ |
| 2023-12-11 | Roche Global Development | New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma roche.com ↗ |
| 2022-12-23 | Roche Global Development | FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2022-12-12 | Roche Global Development | Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma roche.com ↗ |
| 2022-07-06 | Roche Global Development | FDA grants Priority Review to Roche’s Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2022-06-08 | Roche Global Development | European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma roche.com ↗ |
| 2022-04-22 | Roche Global Development | 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 | Roche Global Development | Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab roche.com ↗ |
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 NCT06926205 ↗53 |
| 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 ↗ |