Nivolumab (Opdivo) improved overall survival compared with placebo among patients with unresectable advanced or recurrent gastric cancer, according to an announcement by Bristol-Myers Squibb.1
The multicenter, double-blind, phase 3 ONO-4538-12 trial (ClinicalTrials.gov Identifier: NCT02267343), which evaluated the efficacy and safety of nivolumab among patients with unresectable advanced or recurrent gastric cancer refractory or intolerant to standard therapy, achieved its primary end point of overall survival.
Patients from Japan, Korea, and Taiwan were randomly assigned to receive nivolumab 3 mg/kg intravenously or placebo every 2 weeks until disease progression or unacceptable toxicity. Secondary outcomes measures included progression-free survival, objective response rate, duration of response, and safety.
Findings from the study will be submitted for presentation at an upcoming medical meeting.
Nivolumab is a programmed death-1 immune checkpoint inhibitor approved by the U.S. Food and Drug Administration for the treatment of advanced head and neck cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and classical Hodgkin lymphoma.
- Opdivo (nivolumab) demonstrates overall survival benefit in patients with unresectable advanced or recurrent gastric cancer in phase 3 study. Bristol-Myers Squibb website. http://news.bms.com/press-release/bmy/opdivo-nivolumab-demonstrates-overall-survival-benefit-patients-unresectable-advan. Updated November 10, 2016. Accessed November 11, 2016.