Opdivo filing at EMA is validated for combination with chemotherapy for first line treatment of gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.

Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Type II Variation Marketing Authorization Application (MAA) for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with advanced or metastatic gastric cancer (GC), gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma (EAC). Validation of the application confirms that the submission is complete and initiates the EMA’s centralized review process. The filing is based on results from the pivotal Phase III 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 tumors express PD-L1 with a combined positive score (CPS) greater than 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 greater than 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.