Roche announced that its Phase 3 CELESTIMO study evaluating Lunsumio (mosunetuzumab) in combination with lenalidomide versus MabThera/Rituxan (rituximab) plus lenalidomide met its primary endpoint in people with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) who had received at least one prior line of treatment.

The study demonstrated a statistically significant and clinically meaningful improvement in Progression-Free Survival (PFS) with the Lunsumio and lenalidomide combination. Overall Survival (OS) data remained immature at the time of the interim analysis.

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

CELESTIMO is a confirmatory Phase 3 study intended to support conversion of Lunsumio’s accelerated approval and conditional marketing authorisation as monotherapy for third-line or later (3L+) FL into full approval. The study is also intended to support a potential indication for Lunsumio in second-line or later (2L+) FL.

Lunsumio is a CD20xCD3 bispecific antibody designed to bind to CD20 on B cells and CD3 on T cells, redirecting T cells to target and eliminate malignant B cells. The medicine is currently approved for adults with third-line or later R/R FL and is available in intravenous and subcutaneous formulations.

Roche is also evaluating Lunsumio across additional settings, including Diffuse Large B-Cell Lymphoma (DLBCL) and earlier lines of FL treatment. The Phase 3 MorningLyte study is ongoing in first-line FL, while the US Food and Drug Administration has accepted a supplemental Biologics License Application for Lunsumio in combination with Polivy (polatuzumab vedotin) in second-line or later DLBCL based on results from the SUNMO study.

Follicular lymphoma is an indolent form of non-Hodgkin lymphoma that commonly follows a pattern of remission and relapse. Treatment can become more challenging following successive relapses.