Genentech's Lunsumio-Lenalidomide Regimen Meets Primary Endpoint in Phase III CELESTIMO Follicular Lymphoma Study

Product / Tech Impact 4
โดย Business Wire·USCH·Read original
Summary · why it matters

Genentech, a member of the Roche Group, announced that the Phase III CELESTIMO study of Lunsumio, or mosunetuzumab-axgb, in combination with lenalidomide versus Rituxan plus lenalidomide in people with relapsed or refractory follicular lymphoma who have received at least one prior line of treatment met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival at the interim analysis. Overall survival data were immature at the time of interim analysis, and 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. CELESTIMO is a confirmatory study required to convert the accelerated approval and conditional marketing authorization of Lunsumio monotherapy for third-line or later follicular lymphoma to full approval, as well as to secure an indication in second-line or later follicular lymphoma. Levi Garraway, chief medical officer and head of Global Product Development, said the results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting. Lunsumio is already approved for people with third-line or later follicular lymphoma in 60 countries worldwide and has been used to treat over 3,800 patients.

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Health Care▲ · 1 stocks
Roche Holding AG
ROP
▲ PositiveTechnologyrelevance

Roche's Genentech reported the Phase III CELESTIMO study of Lunsumio plus lenalidomide met its primary endpoint with significant PFS improvement, supporting full approval and earlier-line use.

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Off-coverage companies 1

Genentech, Inc.Private▲ Positive
Technologyrelevance

Genentech's Lunsumio-lenalidomide combination met the primary endpoint in the Phase III CELESTIMO follicular lymphoma study, a confirmatory trial for full approval.

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