The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
Bristol Myers Squibb (BMS) 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-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS).
The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
“Gastric and gastroesophageal junction cancers, along with esophageal adenocarcinomas, are among the deadliest in the world, and there has been no major advancement for HER2-negative patients in many years,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “With the results of the CheckMate -649 trial, Opdivo plus chemotherapy is the first regimen to deliver superior overall survival versus chemotherapy alone in this patient population. We look forward to the European Commission’s decision and to potentially bringing this new treatment to address the remaining high unmet need.”
The positive opinion is based on results from the pivotal Phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) was compared to treatment with chemotherapy alone. Results showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic GC, GEJ cancer or EAC whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5 (the primary endpoints of the study). The statistically significant OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS ≥ 1 and in the all-randomized population. The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments.