Opdivo (nivolumab) success inONO-4538-12, a Phase III study for unresectable advanced or recurrent gastric cancer. BMS + Ono Pharma

Bristol-Myers Squibb Company (BMS) announced that ONO-4538-12, a Phase III, randomized, double-blind clinical trial evaluating the efficacy and safety of Opdivo (nivolumab) in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of overall survival (OS). Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for Opdivo, conducted the ONO-4538-12 trial. The companies will work with investigators on the future presentation of the study results.

Patients with advanced or recurrent gastric cancer generally have a poor prognosis, and there are currently no standard-of-care treatment options for patients who fail to respond to or who are intolerant of standard chemotherapy. With the results from the ONO-4538-12 study, Opdivo is now the first Immuno-Oncology agent to demonstrate a survival benefit for this patient population.

ONO-4538-12 is a multicenter, double-blind, randomized, placebo-controlled, Phase III clinical trial conducted in Japan, Korea and Taiwan, aiming to evaluate the efficacy and safety of Opdivo in patients with unresectable advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to, or intolerant of, standard therapy. In this study, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The primary endpoint, overall survival, was assessed for the superiority of Opdivo versus placebo.