Opdivo meets endpoint for non-small cell lung cancer in CheckMate study

Bristol-Myers Squibb announced that the Phase III study CheckMate -078, evaluating Opdivo (nivolumab) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC), was stopped early because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared with the control arm. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. The results represent the first Phase III trial to show an overall survival benefit with a PD-1 inhibitor in the Chinese patient population. The company will now evaluate the CheckMate -078 data and work with investigators on the future presentation and publication of the results.

CheckMate -078 is a multinational Phase III study with predominantly Chinese patients. The Company submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration (CFDA) for the proposed indication of previously treated NSCLC, which has been accepted by the CFDA. Based on the topline results, nivolumab has the potential to become the first Immuno-Oncology (I-O) treatment approved for previously treated lung cancer patients in China.