CHMP recommends Opdivo + Yervoy for first line treatment of metastatic esophageal squamous cell carcinoma – BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression greater than 1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.

The positive opinion is based on results from the Phase III CheckMate -648 trial, which showed that treatment with Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to fluoropyrimidine- and platinum-containing chemotherapy at the pre-specified interim analysis in patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression greater than 1% (median, 13.7 months vs 9.1 months, HR = 0.64; 98.6% CI: 0.46 to 0.90; p-value = 0.001). The safety profile of Opdivo plus Yervoy was consistent with previously reported studies. Results from CheckMate -648 were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021.