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

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

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.