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Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) plus Chemotherapy for First-Line Treatment of Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1...

Published: 2022-02-25 11:55:00 ET

Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated significantly improved overall survival compared to chemotherapy

PRINCETON, N.J.--(BUSINESS WIRE)--

Bristol Myers Squibb (NYSE:BMY):

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) plus Chemotherapy for First-Line Treatment of Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1%

Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.

“This positive CHMP opinion brings us one important step closer to providing another promising treatment option for an often aggressive disease,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “The clinical data for Opdivo plus chemotherapy show the meaningful benefit this treatment combination may bring to patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.”

The positive opinion is based on results from the Phase 3 CheckMate -648 trial, which showed that treatment with Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy alone at the pre-specified interim analysis in patients with unresectable advanced, recurrent, or metastatic ESCC with tumor cell PD-L1 expression ≥1% (median, 15.4 months vs 9.1 months, HR = 0.54; 99.5% CI: 0.37 to 0.80; p-value

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