Roche has reported positive Phase 3 results for Lunsumio (mosunetuzumab) combined with lenalidomide in people with relapsed or refractory follicular lymphoma.
The CELESTIMO study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with MabThera/Rituxan (rituximab) plus lenalidomide.
The trial included people with relapsed or refractory follicular lymphoma who had received at least one previous line of treatment. Roche said overall survival data were not yet mature at the time of the interim analysis.
The safety profile of the Lunsumio and lenalidomide combination was consistent with the known safety profiles of the individual medicines. Roche reported that no new safety signals were identified during the study.
The company plans to submit the CELESTIMO results to health authorities and present the findings at a future medical meeting.
Lunsumio is a CD20xCD3 bispecific antibody designed to help the immune system target and destroy cancer cells. The treatment is being developed with flexible administration options, including intravenous and subcutaneous delivery, and can be used in an outpatient setting.
Levi Garraway, chief medical officer and head of global product development at Roche, said the CELESTIMO results suggest that a two-drug outpatient Lunsumio regimen could provide another treatment option for people with relapsed or refractory follicular lymphoma.
CELESTIMO is also an important regulatory study for Lunsumio. It is intended to support conversion of the medicine’s accelerated approval and conditional marketing authorisation for third-line or later follicular lymphoma into full approval. The study could also support an indication for patients receiving treatment in the second line or later.
Lunsumio is currently approved for third-line or later follicular lymphoma in 60 countries, according to Roche, and has been used to treat more than 3,800 patients.
Roche is also studying Lunsumio in other B-cell cancers, including diffuse large B-cell lymphoma (DLBCL). The US Food and Drug Administration recently accepted a supplemental Biologics License Application for Lunsumio combined with Polivy (polatuzumab vedotin) in second-line or later DLBCL based on results from the SUNMO study.
Meanwhile, the Phase 3 MorningLyte study is evaluating Lunsumio and lenalidomide in patients with previously untreated, or first-line, follicular lymphoma.
The latest CELESTIMO results add to Roche’s ongoing efforts to expand the use of Lunsumio across different stages of follicular lymphoma and other B-cell malignancies.