New Hope For Stomach Cancer: Immunotherapy Drug Opdivo Now Approved As a First Treatment

The Food and Drug Administration has just approved the immunotherapy drug Opdivo (also called nivolumab) in combination with certain types of chemotherapy for the treatment of advanced or metastatic gastric cancer, and gastric cancer that involves the esophagus. This is the first time the FDA has approved an immunotherapy drug as the primary therapy for stomach cancer.

Dr. Paul Oberstein, director of the Gastrointestinal Medical Oncology Program at NYU Langone's Perlmutter Cancer Center, tells SurvivorNet the approval is an important development for patients.

“This therapy had previously been approved for later stages of disease and this approval will give us the opportunity to utilize this important therapy in a larger group of patients at the beginning of therapy,” Dr. Oberstein says.

According to the FDA, there are approximately 28,000 new diagnoses of gastric cancer each year in the U.S. With currently available therapy, overall survival is generally poor; the rate of cure with resection (surgery) is very low and the survival rate for all stages is 32%. The 5-year survival rate for advanced or metastatic gastric cancer is 5%.

“Gastric cancer is an increasing cause of cancer death worldwide and although chemotherapy provides benefits alone, the ability to add Opdivo to chemotherapy means that we can potentially achieve better outcomes for our patients,” Dr. Oberstein says. “This approval will also stimulate further research into immunotherapy combinations and hopefully lead to more advances in customizing therapy based on each patient’s specific tumor.”

Checkpoint inhibitors such as Opdivo switch off a part of the immune system that is blocking the body from fighting the cancer. This allows immune cells to recognize and eliminate cancer cells more effectively.

Opdivo was tested using 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. The 789 patients who received Opdivo with chemotherapy, on average, lived longer than the 792 patients who received only chemotherapy.  Median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone. It’s important to remember that every patient is different and response to treatments do vary.

In June, the FDA approved Opdivo for patients with advanced esophageal squamous cell carcinoma (ESCC) whose disease had progressed with prior treatment. And these latest approvals represent a wave of new approved uses for immunotherapy.

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