The European Commission (EC) has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%.
The EC’s decision is based on results from the Phase 3 CheckMate -648 trial, in which 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. 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, BMS announced.
“Opdivo plus Yervoy is one of two newly-approved Opdivo-based combination treatments in the EU to show superior survival benefit to chemotherapy alone in this group of patients,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “ESCC is an incredibly aggressive cancer and as the disease progresses, it becomes even harder to treat. The ability to use Opdivo plus Yervoy in the first-line setting for these advanced patients may help improve their survival outcomes compared to chemotherapy alone.”
The EC approval allows for the use of Opdivo plus Yervoy for the first-line treatment of adults with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥ 1% in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway, the company said.
The EC has also approved Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with PD-L1 expression ≥ 1%.