Genentech, a member of the Roche Group, has announced positive results from the Phase III CELESTIMO study evaluating Lunsumio in follicular lymphoma patients.
The trial assessed Lunsumio, also known as mosunetuzumab, in combination with lenalidomide against Rituxan plus lenalidomide in relapsed or refractory follicular lymphoma cases.
Patients enrolled in the study had received at least one prior line of treatment, making the trial population broader than Lunsumio’s currently approved indication.
The study met its primary endpoint, with results demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for patients receiving Lunsumio.
Overall survival data were immature at the time of interim analysis, meaning longer follow-up will be required before those results can be assessed fully.
The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified.
CELESTIMO serves as a confirmatory study required to convert Lunsumio’s accelerated approval into a full regulatory approval and to secure an expanded second-line or later indication.
The FDA granted Lunsumio accelerated approval in December 2022 based on response rate data alone, in patients who had received at least two prior lines of therapy.
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells.
This dual targeting approach activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells driving the disease.
The therapy is administered as a fixed-duration regimen, a meaningful distinction in a disease that typically requires long-term or lifelong management for many patients.
Lunsumio is available in both intravenous and subcutaneous formulations, with the subcutaneous version, Lunsumio Velo, receiving FDA accelerated approval in December 2025.
Follicular lymphoma is the most common slow-growing form of non-Hodgkin lymphoma, accounting for approximately one in five cases of the broader disease category.
The condition typically responds well to initial treatment but is characterised by cycles of remission and relapse, with each relapse generally making the disease harder to manage.
Roche plans to submit the CELESTIMO data to health authorities globally to support full approval and an expanded indication, with detailed results to be presented at an upcoming medical meeting.