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Bristol Myer : Phase 3 Trial On Head & Neck Cancer Fails To Meet Primary Endpoints

Bristol Myers Squibb (BMY) said that phase 3 CheckMate-651 trial, which evaluated opdivo or nivolumab plus yervoy or ipilimumab versus EXTREME Regimen as First-Line Treatment for Squamous Cell Carcinoma of the Head and Neck, did not meet its primary endpoints.

The study results showed a clear, positive trend towards overall survival in patients whose tumors express PD-L1 with a combined positive score greater than or equal to 20.

The safety profile of Opdivo and Yervoy in the trial was consistent with previously reported studies in solid tumors.

"...We are disappointed that these results did not reach statistical significance, and we remain committed to advancing research and supporting patients with this difficult-to-treat cancer," said Abderrahim Oukessou, M.D., vice president, thoracic cancers, development lead, Bristol Myers Squibb.

Opdivo monotherapy previously demonstrated a survival benefit in adults with recurrent or metastatic squamous cell carcinoma of the head and neck  after platinum-based therapy in the CheckMate -141 trial. Based on theresults, the U.S. Food and Drug Administration and the European Medicines Agency approved Opdivo for this indication in 2016.

In addition, Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five different tumors to date: non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

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