South San Francisco-based Genentech, a unit of Swiss pharmaceutical giant Roche Holding AG, announced Thursday that its Lunsumio-based regimen significantly improved progression-free survival in follicular lymphoma (FL) in the Phase III CELESTIMO study.
The trial evaluated Lunsumio (mosunetuzumab-axgb) in combination with lenalidomide versus Rituxan (rituximab) plus lenalidomide and met its primary endpoint at interim analysis. FL is the most common slow-growing form of non-Hodgkin lymphoma, accounting for roughly one in five cases. Although it typically responds well to treatment, the disease is characterized by periods of remission and relapse.
Lunsumio is part of Genentech's CD20xCD3 bispecific antibody program. The CELESTIMO study serves as a confirmatory trial required to convert the accelerated approval — or conditional marketing authorization — of Lunsumio monotherapy for third-line or later FL into full approval, and to secure an indication for second-line or later FL.
Genentech said the results demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression in patients with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were noted as immature at the time of the interim analysis. The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual medicines, with no new safety signals identified.
Levi Garraway, chief medical officer and head of Global Product Development at Genentech, said the CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer patients "an effective new option earlier in their treatment journey." The company plans to submit the study data to health authorities and present at an upcoming medical meeting.
In a separate development, the U.S. Food and Drug Administration recently accepted the supplemental Biologics License Application for Lunsumio in combination with Polivy (polatuzumab vedotin-piiq) for second-line or later diffuse large B-cell lymphoma (DLBCL), based on the SUNMO study.
