Genentech: Lunsumio plus lenalidomide improves PFS in Phase III CELESTIMO for relapsed/refractory follicular lymphoma

Study results

Phase III CELESTIMO met its primary endpoint at the interim analysis, demonstrating a statistically significant and clinically meaningful improvement in progression‑free survival for Lunsumio (mosunetuzumab‑axgb) in combination with lenalidomide versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of systemic therapy. Overall survival data were immature at the time of the interim analysis.

Safety and reporting

The safety profile of the Lunsumio plus lenalidomide combination was consistent with the known profiles of the individual study medicines and no new safety signals were identified. Genentech said the data will be submitted to health authorities and presented at an upcoming medical meeting.

Regulatory context

CELESTIMO serves as the confirmatory trial required to convert the accelerated approval/conditional marketing authorization of Lunsumio monotherapy for third‑line or later follicular lymphoma to full approval and to secure an indication in second‑line or later disease.

Programme status

Lunsumio is part of Genentech’s CD20xCD3 bispecific antibody programme, designed for outpatient use with flexibility between intravenous and subcutaneous administration. It is approved for 3L+ FL in 60 countries and has been used to treat more than 3,800 patients. The FDA recently accepted a supplemental BLA for Lunsumio in combination with Polivy for 2L+ DLBCL based on SUNMO, and the Phase III MorningLyte study is ongoing in first‑line FL.