FDA grants approval of nivolumab in combination with chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma irrepsective of PD-L1 expression status

Approval based on Phase 3 CheckMate -649 trial which demonstrated superior overall survival (HR 0.80; 95% CI: 0.71 to 0.90; P=0.0002) and progression-free survival (HR 0.68; 95% CI: 0.58 to 0.79; P<0.0001) with nivolumab in combination with chemotherapy vs chemotherapy alone.

Source:

Biospace Inc.