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by Dr. C.H. Weaver M.D. 1/2019

The immune-stimulating agent Opdivo® (nivolumab) appears to significantly improve overall survival among patients with advanced stomach cancer for which no standard treatment options exist. Opdivo is not yet approved for stomach cancer.

Stomach cancer (gastric cancer), is the third leading cause of cancer-related deaths worldwide. Overall, the 5-year survival rate for patients with gastric cancer is 30.4%. However, once the cancer has spread from the stomach to distant sites in the body, the 5-year survival rate drops to 5%, indicating the need for novel treatment options.

Opdivo is an agent that stimulates the immune system to recognize cancer cells in the body, and mount an attack against them. Opdivo is already approved for several different types of cancers, and continues to be evaluated in clinical trials in patients with cancer.

Researchers recently conducted a phase III clinical trial, referred to as the ONO-4538-12 trial, to evaluate the effectiveness of Opdivo in the treatment of patients with advanced gastric cancer. The trial included patients in Japan, Korea and Taiwan, countries in which gastric cancer rates are known to be high. The patients in the trial had advanced gastric cancer that could not be surgically removed and had either stopped responding to available standard therapy options, or the patients were not able to tolerate standard therapies. The patients were divided into two groups: one group was treated with Opdivo, and the other group received placebo (inactive substitute), and their results were directly compared.

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  • Patients treated with Opdivo had a significantly improved overall survival time compared to those who received placebo.

These are the first results to demonstrate an improvement in survival with the use of an immunotherapeutic agent among patients with advanced gastric cancer who have no standard treatment options available to them. However, Opdivo is still an investigative agent for the treatment of stomach cancer.

Reference: Bristol-Myers Squibb Company. Press Release: Opdivo (nivolumab) Demonstrates Overall Survival Benefit in Patients With Unresectable Advanced or Recurrent Gastric Cancer in Phase 3 Study. Available at: Opdivo (nivolumab) Demonstrates Overall Survival Benefit in Patients With Unresectable Advanced or Recurrent Gastric Cancer in Phase 3 Study. Accessed November 20, 2016.