EU approves Opdivo + Yervoy for oesophageal squamous cell carcinoma
The EC has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumor cell PD-L1 expression of at least 1%.
The approval 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 OSCC 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.
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