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The FDA approved nivolumab (Opdivo) plus chemotherapy as the first immunotherapy-containing regimen for previously untreated advanced/metastatic .

The approval encompasses gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma and follows FDA for the nivolumab-chemotherapy combination earlier this year.

"Today's approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic cancer who are being treated for the first time," said Richard Pazdur, MD, of the FDA Center for Drug Evaluation and Research, in a statement. "The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer."

Support for the approval came from the randomized phase III CheckMate 649 trial, which compared chemotherapy with or without nivolumab in 1,571 patients with untreated advanced/metastatic gastroesophageal cancer. The addition of nivolumab increased median overall survival (OS) from 11.6 months with chemotherapy alone to 13.8 months. The analysis showed that chemotherapy plus nivolumab improved OS in patients with both a PD-L1 combined positive score (CPS) of ≥1% and a CPS ≥5%.

The most common side effects of the nivolumab combination therapy included peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.

"Nivolumab is the first PD-1 inhibitor to demonstrate superior overall survival and [progression-free survival] in combination with chemotherapy in previously untreated patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma," said principal investigator Markus Moehler, MD, of Johannes-Gutenberg University Clinic in Mainz, Germany, during the virtual meeting of the European Society for Medical Oncology. "We achieved statistical significance for both primary endpoints and for all formally tested secondary endpoints."

"No safety signals were identified for chemo and nivolumab. Therefore, we hope that nivolumab and chemotherapy will present a new potential standard treatment for patients with advanced gastric, gastroesophageal juncture, and esophageal carcinoma," he added.

FDA granted the new indication for nivolumab to Bristol Myers Squibb.

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