SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, affiliated to Swiss drug major Roche Holding AG (RHHBY, RO.SW, ROG.SW), on Thursday announced that its Lunsumio-based regimen significantly improved progression-free survival in Follicular Lymphoma or FL in phase III CELESTIMO study.
The trial evaluating Lunsumio (mosunetuzumab-axgb) in combination with lenalidomide versus Rituxan (rituximab) plus lenalidomide met its primary endpoint at the interim analysis.
FL is the most common slow-growing form of non-Hodgkin lymphoma, accounting for about one in five cases. Though it typically responds well to treatment, it is often characterized by periods of remission and relapse.
Lunsumio is part of Genentech's industry-leading CD20xCD3 bispecific antibody program.
CELESTIMO is a confirmatory study required to convert the accelerated approval/conditional marketing authorization of Lunsumio monotherapy for third-line or later FL to full approval, as well as to secure an indication in second-line or later FL.
Genentech said the study showed a statistically significant and clinically meaningful reduction in the risk of disease progression in people with relapsed or refractory follicular lymphoma who have received at least one prior line of treatment.
The company noted that overall survival 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.
The company plans to submit data from the study to health authorities and to present at an upcoming medical meeting.
Levi Garraway, chief medical officer and head of Global Product Development, stated, 'The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey.'
The U.S. Food and Drug Administration recently accepted the supplemental Biologics License Application for Lunsumio in combination with Polivy (polatuzumab vedotin-piiq) for 2L+ DLBCL based on the SUNMO study.
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