Bristol’s Checkmate-331 Failure Not Likely To Endanger SCLC Labeling For Opdivo

The failure of Bristol-Myers Squibb Co.’s Opdivo to meet an overall survival endpoint compared to standard-of-care chemotherapy in a Phase III confirmatory trial in small-cell lung cancer is a disappointment, but several analysts predict that due to a lack of treatment options for patients, the PD-1 inhibitor will keep the third-line SCLC indication obtained less than two months ago.

Bristol reported top-line findings from the open-label Checkmate-331 study Oct. 12, showing Opdivo (nivolumab) failed to meet a primary endpoint of OS compared to SOC – either topotecan or amrubicin, where the latter is approved. Opdivo obtained accelerated approval in mid-August to treat metastatic SCLC in patients who have progressed after chemotherapy and at least one other therapeutic regimen, which was the first new SCLC approval in roughly 20 years