ASCO: Strong data for Bristol-Myers Opdivo in NSCLC

US pharma major Bristol-Myers Squibb (NYSE: BMY) on Friday announced that Opdivo (nivolumab) is the first PD-1 inhibitor to demonstrate superior overall survival versus standard of care (docetaxel) in an open-label, randomized Phase III study (CheckMate -057) evaluating previously-treated patients with advanced, non-squamous non-small cell lung cancer (NSCLC).

Opdivo is part of a new class of drugs that harness the immune system to fight cancer. Analysts estimate annual peak sales of immuno-oncology drugs will reach between $35 billion and $40 billion within the next decade.

In the checkmate – 057 study, presented at the annual meeting of the American Society of Clinical Oncology (ASCO), a 27% reduction in the risk of progression or death – the primary study endpoint – was reported for Opdivo (n=292) versus docetaxel (n=290) based upon a hazard ratio of 0.73 (96% CI, 0.59-0.89; P = 0.0015). Opdivo was associated with a doubling of overall median survival across the continuum of PD-L1 expression, starting at 1% level of expression, in the trial. The safety profile of Opdivo in CheckMate -057 was favorable versus docetaxel with grade 3–5 treatment-related adverse events reported in 10% of patients who were treated with Opdivo versus 54% in the docetaxel arm.