Roche announced its Phase III CELESTIMO study met its primary endpoint, showing a Lunsumio-based regimen significantly improves progression-free survival. The trial evaluated Lunsumio (mosunetuzumab) combined with lenalidomide for patients with relapsed or refractory follicular lymphoma who had undergone at least one prior therapy.
Interim analysis demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared to the standard rituximab plus lenalidomide treatment. The safety profile of the combination remained consistent with known individual drug profiles with no new safety concerns identified.
Roche will submit these findings to global health authorities to support full regulatory approval. The CELESTIMO study serves as the confirmatory trial required to convert Lunsumio’s current accelerated approvals to full approval.
Positive results could support the drug's use in earlier stages of treatment. Follicular lymphoma is the most common slow-growing form of non-Hodgkin lymphoma.