Phase III trial (ONO-4538-12) of Opdivo (nivolumab) success for treatment of previously treated advanced, refractory, gastric cancer.-BMS

BMS announced the results of ONO-4538-12 study demonstrating Opdivo (nivolumab) significantly reduced the risk of death by 37% (HR 0.63; p<0.0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current standard-of-care treatments.

ONO-4538-12 is a Phase III, randomized, double-blind, placebo-controlled clinical trial evaluating Opdivo’s efficacy and safety in such patients. The primary endpoint of the study is overall survival (OS). Median OS was 5.32 months (95% CI: 4.63 to 6.41) for patients treated with Opdivo, compared to 4.14 months (95% CI: 3.42 to 4.86) (p<0.0001) for those treated with placebo. In addition, the 12-month OS in the Opdivo group was 26.6% (95% CI: 21.1 to 32.4) versus 10.9% (95% CI: 6.2 to 17.0) in the placebo group. Patients treated with Opdivo also experienced an objective response rate of 11.2% (95% CI: 7.7 to 15.6) compared to 0% (95% CI: 0.0 to 2.8) with placebo and a median duration of response of 9.53 months (95% CI: 6.14 to 9.82), which were secondary endpoints.

The safety profile of Opdivo was consistent with previously reported studies in solid tumors. Treatment-related adverse events (TRAEs) of any grade and Grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated patients, respectively. The Grade 3/4 TRAEs reported in more than 2% of patients were diarrhea, fatigue, decreased appetite, pyrexia, as well as increased AST and ALT in the Opdivo group, and fatigue and decreased appetite in the placebo group. The Opdivo and placebo-treated patients had similar rates of TRAEs leading to discontinuation, 2.7% and 2.5%, respectively. The ONO-4538-12 data were presented in a late-breaking oral presentation (Abstract #2) at the 2017 Gastrointestinal Cancers Symposium in San Francisco, California.