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 <0.001). Additionally, this combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) and a clinically meaningful increase in objective response rate (ORR) in patients whose tumors express PD-L1. The safety profile of Opdivo plus 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.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial.

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy (N=325) or Opdivo plus fluorouracil and cisplatin (N=321) against fluorouracil plus cisplatin alone (N=324) in patients with previously untreated, unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients with tumor cell PD-L1 expression ≥1% for both Opdivo-based combinations versus chemotherapy. Secondary endpoints of the trial include OS and PFS by BICR in the all-randomized population.

In the Opdivo plus chemotherapy arm patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² on Day 1 of four-week cycle. Patients received Opdivo for up to 24 months or until disease progression, unacceptable toxicity or withdrawal of consent, and chemotherapy until disease progression, unacceptable toxicity, or withdrawal of consent.

In the Opdivo plus Yervoy arm patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region and country. Squamous cell carcinoma accounts for approximately 60% of esophageal cancer cases in Europe. Full Release

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