Bristol-Myers Squibb has stopped an open-label, randomized Phase III study (CheckMate -017) evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm.

Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody and is one of the company’s key anticancer drugs. It was approved by the US Food and Drug Administration in 2014 for treating patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials as a monotherapy or in combination with other therapies. The company said that the data for its NSCLC trial that showed a survival advantage was the first time that an anti-PD1 immune checkpoint inhibitor showed survival advantage in treating lung cancer.

CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.

Source: Bristol-Myers Squibb