The FDA has accepted and granted priority review to an application for nivolumab (Opdivo, Bristol Myers Squibb) combined with chemotherapy as a first-line treatment of metastatic gastric cancer, gastroesophageal junction cancer (GEJ) and esophageal adenocarcinoma. 

The Agency has also granted priority review to a separate application for nivolumab as an adjuvant therapy for patients with resected esophageal or GEJ cancer. 

The FDA based these designations on results from the CheckMate-649 and CheckMate-577 trials. 

“Today’s filing acceptance by the FDA marks important progress for the gastrointestinal cancer community and builds on our momentum of advancing immunotherapies to help improve the lives of those with advanced gastric and esophageal tumors,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol Myers Squibb, said in a press release. “The positive results of the CheckMate -649 trial are potentially practice-changing, and we look forward to working with the FDA to possibly bring the first immunotherapy-based treatment option to front-line patients, for whom no novel therapies have been made available in the last decade.”

The phase 3 CheckMate-649 trial evaluated nivolumab plus FOLFOX or CapeOX chemotherapy  compared with chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric or GEJ cancer or esophageal adenocarcinoma. 

Researchers reported a statistically significant improvement in overall survival and progression-free survival among patients with a PD-L1 combined positive score of 5 or greater. 

The phase 3 CheckMate-577 trial assessed nivolumab as an adjuvant therapy in 794 patients with resected esophageal or GEJ cancer who have received neoadjuvant chemoradiation therapy and have not achieved a pathological complete response. Study results found nivolumab doubled median disease-free survival versus placebo in the study population. 

Follow-up for overall survival is ongoing. 

The FDA assigned a Prescription Drug User Fee Act goal date of May 2021 for both applications.