EU approves Opdivo plus chemotherapy for oesophageal squamous cell carcinoma
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression of at least 1%.
The EC’s decision is based on results from the Phase III CheckMate -648 trial, in which Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy alone at the pre-specified interim analysis. The safety profile of Opdivo with chemotherapy 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.
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