Bristol Myers Squibb today announced an update on the Phase 3 CheckMate -651 trial comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to the EXTREME regimen (cetuximab, cisplatin/carboplatin and fluorouracil) as a first-line treatment in platinum-eligible patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Although Opdivo plus Yervoy showed a clear, positive trend towards overall survival (OS) in patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 20, the study did not meet its primary endpoints. The safety profile of Opdivo and Yervoy in this trial was consistent with previously reported studies in solid tumors.

“Numerous studies have shown long-term survival improvements with the Opdivo plus Yervoy combinationacross various tumor types, bringing benefit to patients around the world,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers, development lead, Bristol Myers Squibb. “In the CheckMate -651 trial, Opdivo plus Yervoy showed a positive overall survival trend relative to EXTREME in patients with squamous cell carcinoma of the head and neck whose tumors express PD-L1, despite the control arm performing better than expected based on historical data. 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.”

Opdivo monotherapy previously demonstrated a survival benefit in adults with recurrent or metastatic SCCHN after platinum-based therapy in the CheckMate -141 trial. Based on these results, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -651 clinical trial. The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community.