The FDA has approved nivolumab (Opdivo) in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, the agency announced on April 16. The drug is the first FDA-approved immunotherapy for first-line treatment of gastric cancer.
Efficacy of the monoclonal antibody was evaluated in a multicenter randomized, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. Median survival was 13.8 months for the 789 patients who received the drug plus chemotherapy compared to 11.6 months for the 792 patients who received chemotherapy alone. The most common side effects include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain. The drug can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.