Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) revealed that they’re stopping a Phase 3 cervical cancer trial early after Libtayo showed cutting the risk of death by 31% over chemotherapy.
- The Independent data monitoring committee unanimously recommended stopping the trial after reviewing the OS data at an interim analysis, thus paving the way for regulatory approval this year.
- Among 608 participants, exactly half received Libtayo, and half got chemotherapy.
- In the squamous cell carcinoma population, the median overall survival was 11.1 months for Libtayo compared to 8.8 months for chemo, translating to a hazard ratio of 0.73.
- The smaller adenocarcinoma group saw better results, with a difference of 13.3 months versus 7.0 months leading to a hazard ratio of 0.56.
- In the overall population, Libtayo was related to a median survival of 12.0 months compared to 8.5 months on chemo and a hazard ratio of 0.69.
- The trial win comes on the heels of two FDA approvals that came within weeks of each other, one in basal cell carcinoma and another in advanced non-small cell lung cancer, expanding Libtayo’s label.
- No new Libtayo safety signals were observed.
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