FDA approves Genentech’s Lunsumio VELO SC for relapsed/refractory follicular lymphoma
- FDA approved mosunetuzumab-axgb (Lunsumio VELO) SC for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies under accelerated approval.
- SC formulation shortens administration from a 2–4 hour IV infusion to an approximately one-minute injection and is a fixed-duration regimen that can be as short as six months.
- GO29781 (3L+ FL) primary analysis: objective response rate 75% (95% CI 64–83%), complete response rate 59% (95% CI 48–69%), median duration of response 22.4 months.
- Most common adverse reactions (≥20%) included injection site reactions, fatigue, rash, CRS, COVID-19 infection, musculoskeletal pain and diarrhea; CRS occurred in 30% (mostly Grade 1–2) and resolved after a median of two days.
Regulatory decision and indication
The U.S. Food and Drug Administration approved Lunsumio VELO (mosunetuzumab-axgb), a CD20xCD3 bispecific, as a subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The approval is an accelerated approval based on results from the Phase I/II GO29781 study and may require verification in a confirmatory trial for full approval.
Key efficacy results
In the primary analysis of GO29781 in third-line or later patients, objective response rate was 75% (95% CI: 64–83%) and complete response rate was 59% (95% CI: 48–69%). The median duration of response was 22.4 months (95% CI: 16.8–22.8).
Administration and safety profile
The subcutaneous formulation delivers treatment in approximately one minute versus a 2–4 hour intravenous infusion and is given as a fixed-duration regimen that could be as short as six months. Common adverse reactions (≥20%) included injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. CRS occurred in 30% of patients (28% Grade 1–2; 2.1% Grade 3), typically in Cycle 1, and resolved after a median of two days (range: 1–15); CRS can be severe or life‑threatening.
Regulatory and development context
Lunsumio IV was the first bispecific antibody approved for 3L+ follicular lymphoma. Long‑term data from the SC and IV arms were presented at the American Society of Hematology meeting, the European Commission recently granted conditional marketing authorization for Lunsumio SC, and Phase III studies are ongoing evaluating Lunsumio VELO in earlier lines and in combinations (SUNMO and MorningLyte).
Source: Genentech
