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

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

Digital illustration of lung cancer cells in color background

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...

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