Date: 2017-01-19
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 2017 Gastrointestinal Cancers Symposium
Company: Ono Pharmaceutical (Japan) BMS (USA - NY)
Product: Opdivo® (nivolumab)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. In 2011, through a collaboration agreement with Ono Pharmaceutical, BMS expanded its territorial rights to develop and commercialize Opdivo® globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, BMS and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
Disease: gastric cancer
Therapeutic area: Cancer - Oncology
Country: Japan, Republic of Korea, Taiwan
Trial
details: ONO-4538-12 is a Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating Opdivo’s efficacy and safety in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy. The primary endpoint of the study is overall survival (OS). (NCT02267343)
Latest
news: * On January 19, 2017, BMS announced the results of ONO-4538-12 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. 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. These data are being presented in a late-breaking oral presentation at the 2017 Gastrointestinal Cancers Symposium in San Francisco.
