On April 16, 2021, the FDA approved nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, in combination with certain types of chemotherapy, for the initial treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The FDA granted nivolumab priority review and an orphan drug designation for this indication. Nivolumab has been previously approved by the FDA, alone or in combination with other therapies, for the treatment of many types of malignancies, including lung, colorectal, liver, melanoma, urothelial, and head and neck cancers, as well as for classical Hodgkin lymphoma.
The FDA approved this new indication based on results from the phase 3 CheckMate-649 clinical trial, which evaluated nivolumab in combination with fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin. Median survival was 13.8 months for patients who received nivolumab plus chemotherapy versus 11.6 months for patients who received chemotherapy alone.
“These findings are important, reinforcing the potential of this Opdivo-based combination as a standard of care for this population of patients in high need of treatment options that may extend their lives,” said Yelena Y. Janjigian, MD, Chief of Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, and principal investigator of the CheckMate-649 trial, in a press release.
The most common (≥20%) adverse reactions reported in the nivolumab plus chemotherapy arm included peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).