Roche reported that its phase III CELESTIMO trial met its primary endpoint in relapsed or refractory follicular lymphoma after at least one prior systemic therapy.
The regimen—Lunsumio (mosunetuzumab) plus lenalidomide—produced a statistically significant and clinically meaningful improvement in progression-free survival versus rituximab plus lenalidomide (R2).
Overall-survival results were not yet mature at the interim analysis, and Roche has not publicly provided detailed efficacy figures in the initial announcement.
No new safety signals were identified; the combination’s safety profile was consistent with the known profiles of its individual medicines.
The study is confirmatory for Lunsumio’s accelerated/conditional approval in later-line follicular lymphoma and could support use in the second-line-or-later setting. Roche plans to submit the data to health authorities and present them at a forthcoming medical meeting.
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