EU approves Opdivo and chemo for HER2-negative gastric, gastroesophageal junction or oesophageal adenocarcinoma.

The EC’s decision is based on results from the 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 with chemotherapy alone. Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic gastric cancer (GC), GEJ cancer (GEJC) or EAC whose tumors express PD-L1 with a CPS of at least 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 of at least 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.