Roche's Lunsumio Plus Lenalidomide Meets Progression-Free Survival Endpoint in Phase 3 CELESTIMO Trial in Relapsed or Refractory Follicular Lymphoma
Roche announced on Thursday, September 17, 2026 that the Phase 3 CELESTIMO trial met its primary endpoint: Lunsumio (mosunetuzumab) plus lenalidomide produced a statistically significant improvement in progression-free survival versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were immature at the interim analysis, and safety was consistent with the known profiles of both drugs, with no new signals. CELESTIMO is the confirmatory study required to convert the accelerated approval and conditional authorization of Lunsumio monotherapy for third-line or later follicular lymphoma into full approval. Roche will submit the data to health authorities and present them at an upcoming medical meeting.