BMS’s Drug Bags First FDA-Approved Immunotherapy Tag for Initial Treatment of Gastric Cancer

Bristol Myers Squibb announced that its PD-1 Inhibitor, Opdivo plus chemotherapy has become the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Gastric cancer is the third most common cause of cancer mortality with 28,000 new diagnoses each year in the US alone. Patients with this condition have a five-year survival rate of 32% which decreases to just 5% in aggressive or metastatic forms.

Surgery, chemotherapy, and radiation therapy are some of the traditional treatments, but immunotherapies like ramucirumab, pembrolizumab, and trastuzumab have been approved for some advanced gastric cancers. Nevertheless, there are very few drugs for this condition.

On April 16th, the FDA approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for treating patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.

“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, M.D., Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.”

CheckMate-649 Trial

The approval is an outcome of a successful Phase 3 CheckMate -649 trial that evaluated the performance of Opdivo plus chemotherapy vs. chemotherapy alone in 1,581 patients. The chemotherapy of choice was either mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin).

Results showed that the combo therapy registered a superior overall survival (OS). The median survival of patients who received the combo therapy was 13.8 months vs. 11.6 months in the chemotherapy alone arm.

Nausea, fatigue, diarrhea, vomiting, constipation, and musculoskeletal pain were some of the most common side effects of the Opdivo plus chemotherapy combination. Opdivo can lead to serious immune-mediated side effects like colitis, hepatitis, endocrinopathies, and nephritis. Therefore patients with immune problems must alert their healthcare provider.

“In CheckMate -649, Opdivo plus chemotherapy combination significantly improved survival for patients with metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, reducing the risk of death by 20%.1 Additionally, 55% of patients were still alive at one year,” said Yelena Y. Janjigian, M.D., Chief of Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center and the principal investigator of the trial.

“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.”

Five Prime Therapeutics’ FGFR2b targeting antibody, bemarituzumab could be a potential competitor to this Opdivo, chemo combo as a first-line treatment for gastric cancer. In March this year, Amgen acquired Five Prime for $1.9 billion and got hold of the asset.

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