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The U.S. Food and Drug Administration has approved nivolumab (Opdivo®) in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancers.

Nivolumab inhibits PD-1, a protein that blocks the immune system from attacking cancer cells. It is the first first-line immunotherapy treatment to receive approval in the U.S. for patients with gastric cancer, which affects about 28,000 individuals each year. The five-year survival rate for metastatic disease is 5%.

The approval came after a multicenter trial evaluated nivolumab plus chemotherapy in more than 1,500 patients with advanced or metastatic disease. Of the patients who received the treatment regimen, the median overall survival was 14.4 months, compared to 11.1 months for those who received chemotherapy alone. This translates into a 29% decrease in risk of death. Nivolumab plus chemotherapy also resulted in a 32% reduction in the risk of disease progression compared to chemotherapy alone.

Nivolumab isn’t the only treatment offering new hope to advanced gastric cancer patients.

In January, the FDA approved trastuzumab deruxtecan (Enhertu®) for treatment of patients with previously treated HER2-positive advanced gastric cancer. Approximately 1 in 5 gastric cancers are HER2 positive. The trial that led to the approval enrolled patients whose disease had progressed after at least two prior lines of treatment and found patients treated with Enhertu had a 41% reduction in risk of death compared to those treated with chemotherapy alone.

Dr. Rutika Mehta, medical oncologist, Gastrointestinal Oncology Program

Dr. Rutika Mehta, medical oncologist, Gastrointestinal Oncology Program

Recently, the FDA has also given breakthrough designation to bemarituzumab, a monoclonal antibody, plus chemotherapy for advanced gastric cancer. A trial showed response rates increased from 40% to 53% with bemarituzumab, and the drug increased median duration of response from 7.1 months to 12.2 months.

“Things are moving forward faster than they were compared to even two years ago. These advancements have been possible because of patients who volunteered to be part of clinical trials and I encourage patients to seek for clinical trials whenever possible,” said Dr. Rutika Mehta, a medical oncologist in the Gastrointestinal Oncology Program at Moffitt Cancer Center. “With so many drugs being approved, it is important that patients have a discussion with their physician about what is the best treatment option for them.”