Opdivo demonstrated efficacy and improved survival in patients with previously treated advanced gast

Opdivo demonstrated a 37% reduction in the risk of death compared to placebo.

Bristol-Myers Squibb (BMS) has announced the results of ONO-4538-12 demonstrating Opdivo (nivolumab) significantly reduced the risk of death by 37% 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 for patients treated with Opdivo, compared with 4.14 months for those treated with placebo. In addition, the 12-month OS in the Opdivo group was 26.6 versus 10.9% in the placebo group. Patients treated with Opdivo also experienced an objective response rate of 11.2% compared with 0% with placebo and a median duration of response of 9.53 months, which were secondary endpoints.

The safety profile of Opdivo was consistent with previously reported studies in solid tumours. 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.

"ONO-4538-12 is the first randomized, Phase III immuno-oncology trial to demonstrate improved survival for patients with previously treated advanced or recurrent gastric cancer. We find these results with Opdivo encouraging, as gastric cancer is a leading cause of cancer death globally and unmet needs remain for patients with advanced forms of this disease who become intolerant to chemotherapy or for whom such treatment has failed," said Ian M. Waxman, development lead, Gastrointestinal Oncology, BMS.

"These results show a clinical benefit with Opdivo for patients with pretreated advanced or recurrent gastric cancer and establish a strong basis for conducting additional studies with Opdivo as a treatment for patients with gastric cancer," added lead study investigator Yoon-Koo Kang, of the Department of Oncology at the University of Ulsan College of Medicine, Asan Medical Center in Seoul, Korea.