FDA approves Opdivo in combination with chemotherapy for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.- BMS

Bristol Myers Squibb announced that Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the FDA for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status. The approval is based on the Phase III CheckMate -649 trial evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin), compared to chemotherapy (mFOLFOX6 or CapeOX) alone. In the trial of this patient population, Opdivo plus chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients (OS HR 0.80; 95% CI: 0.71 to 0.90; P=0.0002), as well as in patients with PD-L1 combined positive score (CPS) greater than 5 (OS HR 0.71; 95% CI: 0.61 to 0.83; P<0.0001). in an exploratory analysis of all patients, 55% of patients on opdivo in combination with chemotherapy were alive at one year versus 48% of patients on chemotherapy alone. the combination also significantly reduced the risk of disease progression or death compared to chemotherapy alone (pd-l1 cps ? 5: progression-free survival (pfs) hr 0.68; 95% ci: 0.58 to 0.79; p><0.0001). the application was reviewed under the fda’s real-time oncology review (rtor) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. the review was also conducted under the fda’s project orbis initiative, enabling concurrent review by the health authorities in canada, australia, switzerland and brazil.>