FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Regulatory approval: On Dec 22, 2022, the FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. Approval was based on the open-label GO29781 study (n=90 efficacy population), with an independently assessed objective response rate of 80% (60% complete response). The label includes a Boxed Warning for serious or life-threatening cytokine release syndrome.
FDA accelerated approval: mosunetuzumab-axgb (Lunsumio) in R/R follicular lymphoma
Type: Regulatory approval (accelerated approval)
Agency/date: FDA, 2022-12-22
The FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Supporting evidence
Approval was supported by GO29781, an open-label, multicenter, multi-cohort study. The efficacy population included 90 patients with relapsed or refractory follicular lymphoma who had received ≥2 prior systemic therapies, including an anti-CD20 monoclonal antibody and an alkylating agent.
The primary efficacy endpoint was objective response rate (ORR) by an independent review facility using standard criteria for non-Hodgkin’s lymphoma:
- ORR: 80%
- Complete response: 60%
- Among responders (median follow-up 14.9 months), estimated median duration of response: 22.8 months; estimated DOR rates 62% at 12 months and 57% at 18 months.
Safety (label highlights)
Prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS). Warnings/precautions include neurologic toxicity, infections, cytopenias, and tumor flare. In 218 treated patients at the recommended dose: CRS 39%, neurologic toxicity 39%, serious infections 17%, tumor flare 4%; CRS grades included Grade 2: 15%, Grade 3: 2%, Grade 4: 0.5%.