The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo®; Bristol Myers Squibb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC).
The sBLA submission was based on data from the open-label, randomized phase 3 CheckMate -649 trial in adults with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer, GEJC or EAC. Patients were randomized to receive nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy alone; chemotherapy consisted of leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX).
Results showed that among patients whose tumors express PD-L1 with a combined positive score (CPS) greater than or equal to 5, treatment with nivolumab plus chemotherapy led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone. Moreover, a statistically significant OS benefit was observed in all patients randomized to nivolumab plus chemotherapy.
A Prescription Drug User Fee Act target date of May 25, 2021 has been set for this application.
The FDA has also granted Priority Review to a second sBLA for nivolumab for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT).
The sBLA is supported by data from the randomized, double-blind phase 3 CheckMate -577 trial in patients with resected esophageal or GEJ cancer who have received neoadjuvant CRT and have not achieved a pathological complete response. Patients were randomized to receive either nivolumab (n=532) or placebo (n-262). Results showed that the study met its primary end point of disease-free survival.
The FDA is expected to make a decision on this application on May 20, 2021.
1. U.S. Food and Drug Administration accepts for priority review application for Opdivo® (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. [press release]. Princeton, NJ: Bristol Myers Squibb; January 20, 2021.
2. U.S. Food and Drug Administration accepts for priority review application for Opdivo® (nivolumab) as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer. [press release]. Princeton, NJ: Bristol Myers Squibb; January 20, 2021