CheckMate-017 is a Phase 3, open-label study that randomized 272 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or docetaxel 75 mg/m2 intravenously every three weeks.
An analysis by the Data Monitoring Committee (DMC) found that the study met its primary endpoint, in which Opdivo was superior to docetaxel in the overall survival in patients with relapsed/refractory squamous cell NSCLC, leading Bristol-Myers Squibb to stop the comparative portion of the trial.
Patients in the study may have the opportunity to continue or start treatment with Opdivo in an open-label extension, and the company will evaluate the final CheckMate-017 data and work with the investigators for the publication of the results.
Opdivo, a human programmed death receptor-1 (PD-1) blocking antibody, is FDA-approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Opdivo is being further studied for multiple tumor types under a broad, global development program consisting of more than 50 trials and over 7,000 patient participants.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm.