# Mosunetuzumab

Source: https://onco.cc/drugs/mosunetuzumab/  
OnCo record `mosunetuzumab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Mosunetuzumab is a fixed-duration CD20 bispecific approved for follicular lymphoma and studied with polatuzumab in large B-cell lymphoma.

## Summary

Mosunetuzumab is a full-length humanised IgG1 CD20xCD3 bispecific antibody that brings T cells to CD20-positive B cells, given with step-up dosing for a fixed 8 to 17 cycles depending on response. It was approved in December 2022 for relapsed or refractory follicular lymphoma after at least 2 lines, where it produced ORR 80% and CR 60%. In DLBCL, mosunetuzumab plus polatuzumab vedotin met its PFS endpoint in the phase 3 SUNMO trial against R-GemOx in transplant-ineligible relapsed disease in 2025, positioning the chemotherapy-free, outpatient doublet for patients not fit for CAR-T. A subcutaneous formulation was approved in 2025. Cytokine release syndrome occurred in 44% of the follicular lymphoma cohort but was grade 3 or higher in only 2%; Roche develops it. Its distinguishing point is fixed-duration treatment, so patients stop rather than continuing indefinitely.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Lunsumio
- Modality: Bispecific T-cell engager (CD20×CD3)
- Mechanism: Full-length humanised IgG1 CD20×CD3 bispecific with step-up dosing; fixed 8-17 cycles.
- Approvals: US 2022: R/R follicular lymphoma after ≥2 lines (accelerated)
- Dosing: IV or subcutaneous; Step-up 1 mg, 2 mg, 60 mg in cycle 1, 60 mg cycle 2, 30 mg thereafter; 8 cycles if CR, up to 17 if PR/SD
- Toxicity (grade 3+): Cytokine release syndrome 2%; Neutropenia 27%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Mosunetuzumab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Mosunetuzumab

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD20](https://onco.cc/targets/cd20/), [CD3](https://onco.cc/targets/cd3/)
- drugs: [Polatuzumab vedotin](https://onco.cc/drugs/polatuzumab-vedotin/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomi](https://onco.cc/trials/nct04712097/), [A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies](https://onco.cc/trials/nct05207670/), [A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokineti](https://onco.cc/trials/nct04246086/), [A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas](https://onco.cc/trials/nct06090539/), [A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP](https://onco.cc/trials/nct06828991/), [A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma](https://onco.cc/trials/nct03671018/), [A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies](https://onco.cc/trials/nct06634589/), [Mosunetuzumab against rituximab in low tumour burden follicular lymphoma](https://onco.cc/trials/mosun-lbt-fl/), [Mosunetuzumab with lenalidomide in relapsed marginal zone lymphoma](https://onco.cc/trials/mosun-len-mzl/), [SUNMO](https://onco.cc/trials/sunmo/)
- pairings: [CD20 bispecific + CD79b ADC (mosunetuzumab + polatuzumab)](https://onco.cc/pairings/bispecific-plus-adc-lymphoma/)
- terms: [CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one](https://onco.cc/terms/lymphoma-tx-bispecific-step-up/), [Cytokine release syndrome and ICANS: grading and management](https://onco.cc/terms/lymphoma-tx-crs-icans/), [Hepatitis B reactivation before rituximab and other anti-CD20 antibodies](https://onco.cc/terms/lymphoma-tx-hepatitis-b-reactivation/), [Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment](https://onco.cc/terms/lymphoma-tx-immunoglobulin-replacement/), [POD24: progression of follicular lymphoma within two years, and why it changes the plan](https://onco.cc/terms/lymphoma-tx-pod24/), [What the NHS in England funds for lymphoma, appraisal by appraisal](https://onco.cc/terms/lymphoma-tx-uk-access/)
- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- ideas: [Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas](https://onco.cc/ideas/lymphoma-ev-fixed-duration-chemotherapy-free-first-line/)
- key papers: [EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T](https://onco.cc/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/)
- biomarkers: [CD20 expression (CD20-positive)](https://onco.cc/biomarkers/cd20-expression/)

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