CheckMate -057, a pivotal Phase III Opdivo lung cancer trial, stopped early

Bristol-Myers Squibb has announced that CheckMate -057, an open-label, randomised Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC), has stopped early.

The trial was stopped when an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The Company will share these data with health authorities soon.

The CheckMate -057 trial randomised 582 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or docetaxel 75 mg/m2 intravenously every three weeks. The primary endpoint was overall survival.

CheckMate -057 results mark second time Opdivo has demonstrated a survival advantage in lung cancer

“The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Through our Opdivo clinical development program, we seek to bring the potential for long-term survival to a broad range of patients, across lines of therapy and stages of disease.”

CheckMate -057 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -057 data and work with investigators on the future presentation and publication of the results.

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