Bristol-Myers Squibb reports that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous 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. The company said it looks forward to sharing these data with health authorities soon.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the US Food and Drug Administration as a monotherapy in two cancer indications. On March 5, 2015, Opdivo received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. In the US, Opdivo is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (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, in which more than 7,000 patients have been enrolled worldwide.

Source: Bristol-Myers Squibb