Roche announced that the phase III CELESTIMO study evaluating Lunsumio (mosunetuzumab) in combination with lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) who have received at least one prior line of treatment has met its primary endpoint.
Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Overall survival (OS) data were immature at the time of interim analysis. 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. Data will be submitted to health authorities and presented at an upcoming medical meeting.
The CELESTIMO study is a confirmatory trial required to convert the accelerated approval of Lunsumio monotherapy for third-line or later (3L+) FL to full approval, and to secure an indication in second-line or later (2L+) FL. The U.S. Food and Drug Administration recently accepted the supplemental Biologics License Application for Lunsumio in combination with Polivy (polatuzumab vedotin) for 2L+ diffuse large B-cell lymphoma based on the SUNMO study. Results from CELESTIMO support continued expansion of Lunsumio and lenalidomide into earlier FL treatment, with the phase III MorningLyte study ongoing in first-line FL.
Lunsumio is already approved for 3L+ FL in 60 countries worldwide and has been used to treat over 3,800 patients, according to Roche data on file. It is part of Roche's CD20xCD3 bispecific antibody programme and is the only bispecific antibody in lymphoma with the longest follow-up data available.
Follicular lymphoma accounts for approximately one in five cases of non-Hodgkin lymphoma and is the most common indolent form of the disease. More than 110,000 people are diagnosed with FL annually worldwide. The condition typically responds well to treatment but is characterized by periods of remission and relapse, becoming harder to treat with each progression.
Roche has over 25 years of experience in haematology medicine development. Its approved portfolio includes rituximab, obinutuzumab, polatuzumab vedotin, venetoclax in collaboration with AbbVie, emicizumab, crovalimab, Lunsumio and glofitamab. The pipeline includes the investigational bispecific antibody cevostamab, targeting FcRH5 and CD3.
