A randomized phase 3 trial designed to compare nivolumab with chemotherapy for patients with unresectable advanced or recurrent esophageal cancer met its primary endpoint of OS, according to a company-issued press release.
Nivolumab (Opdivo, Bristol-Myers Squibb) is the first immune checkpoint inhibitor to demonstrate a statistically significant OS benefit in this setting for a PD-L1-unselected population.
ONO Pharmaceutical Co. and Bristol-Myers Squibb conducted the global, multicenter, open-label ATTRACTION-3 study to compare IV infusion of nivolumab — an anti-PD-1 monoclonal antibody — with either docetaxel or paclitaxel among patients with resectable advanced or recurrent esophageal cancer refractory to or intolerant of combination therapy with fluoropyrimidine and a platinum-based agent.
Treatment continued until disease progression or onset of severe adverse events.
Results showed nivolumab-treated patients achieved significantly longer OS.
More complete results from this study will be presented at a scientific conference.
Nivolumab has received FDA approval for treatment of patients with several malignancies, including advanced lung cancer, melanoma, advanced kidney cancer, head and neck squamous cell cancer, advanced liver cancer, advanced bladder cancer, classical Hodgkin lymphoma and colorectal cancer.
Ono Pharmaceutical Co. Ltd. Retains all rights to the drug in Japan, South Korea and Taiwan.