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Opdivo First FDA-Approved Immunotherapy for First-Line Treatment of Advanced Gastric Cancer

Web Exclusives - FDA Approvals, Select Drug Profiles

On April 16, 2021, the FDA approved the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma. Nivolumab was the first immunotherapy approved by the FDA for first-line treatment of gastric cancer.

“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

Approximately 28,000 new people are diagnosed with gastric cancer each year in the United States. The overall survival (OS) before the approval of immunotherapy has been generally poor. The rate of cure with resection is very low, and the survival rate for all disease stages is 32%. The 5-year survival rate for advanced or metastatic gastric cancer is 5%.

The FDA approval was based on results of the CHECKMATE-649 study, a randomized, multicenter, open-label clinical trial of 1581 patients with metastatic gastric cancer, GEJ cancer, or esophageal adenocarcinoma. The main efficacy outcome measures in the 955 patients with PD-L1 expression ≥5% were progression-free survival (PFS) and OS.

In the patients with PD-L1 expression ≥5%, the median OS was 14.4 months (95% confidence interval [CI], 13.1-16.2) in the nivolumab plus chemotherapy arm versus 11.1 months (95% CI, 10.0-12.1) in the chemotherapy-alone arm (P <.0001). The median PFS was 7 months (95% CI, 7.0-9.2) in the nivolumab arm versus 6 months (95% CI, 5.6-6.9) in the chemotherapy-alone arm (P <.0001). In the full study population (N = 1581), regardless of PD-L1 status, the addition of nivolumab resulted in a significant OS benefit. The median OS was 13.8 months (95% CI, 12.6-14.6) with nivolumab plus chemotherapy versus 11.6 months (95% CI, 10.9-12.5) with chemotherapy alone (P = .0002).

The most common (≥20%) adverse reactions with nivolumab plus chemotherapy were peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.

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Last modified: August 30, 2021