BMS Celebrates Superior Overall Survival for Opdivo

Bristol-Myers Squibb (BMS) announced on Jan. 11, 2015 that the independent data monitoring committee (DMC) concluded that the end had been reached for the late stage study of Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer. The Phase III study, CheckMate-017, was stopped early for superior overall survival because it indicated a survival advantage with Opdivo, the anti-PD1 immune checkpoint inhibitor. In December 2014, Opdivo was listed, along with its competitor, Keytruda (pembrolizumab), as being one of the most important drugs of 2014. The DMC’s interim analysis may help in the race for approvals in the PD-1 space.

In December 2014, Opdivo was approved by FDA for the treatment of unresectable or metastatic melanoma, and was was granted Breakthrough Therapy, Priority Review, and Orphan Product designations. According to Reuters, Merck announced on Jan. 12, 2015 that it would file an application midyear to expand the use of Keytruda to include non-small cell lung cancer.

BMS announced that it will continue to ensure that eligible patients are given access to Opdivo in an open-label extension. The full results will be released at a later date.

Sources:
BMSReuters