Roche's Lunsumio Combo Meets Primary Endpoint in Phase III CELESTIMO Follicular Lymphoma Study

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Roche announced that the phase III CELESTIMO study of Lunsumio, also known as mosunetuzumab, in combination with Revlimid, or lenalidomide, met its primary endpoint in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. The Lunsumio regimen produced a statistically significant and clinically meaningful improvement in progression-free survival versus MabThera/Rituxan, or rituximab, plus Revlimid, while overall survival data were immature at the interim analysis. The safety profile of Lunsumio plus Revlimid was consistent with the known profiles of the individual medicines, with no new safety signals reported. CELESTIMO is the confirmatory study required to convert Lunsumio monotherapy's accelerated approval and conditional marketing authorization for third-line or later follicular lymphoma into full approval, and it is also intended to support an indication in second-line or later disease. Roche plans to submit the data to health authorities and present it at an upcoming medical conference. Separately, Lunsumio is approved as a fixed-duration monotherapy for third-line or later relapsed or refractory follicular lymphoma in both intravenous and subcutaneous formulations, and in June 2026 the FDA accepted Roche's supplemental biologics license application for Lunsumio VELO in combination with Polivy for relapsed or refractory large B-cell lymphoma, with a decision expected on Feb. 9, 2027.

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Lunsumio plus Revlimid met the primary endpoint in the phase III CELESTIMO follicular lymphoma study, supporting full approval and a broader indication.

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