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Phase III Trial of Bristol-Myers Squibb Lung Cancer Drug Stopped Early
17 April 2015 - - An open-label, randomised Phase III study evaluating US-based pharmaceutical company Bristol-Myers Squibb Co.'s (NYSE: BMY) 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 concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm, the company said on Friday. The company said it looks forward to sharing these data with health authorities soon. CheckMate -057 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb said it 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. CheckMate -057 is a Phase III, open-label, randomised study of Opdivo versus docetaxel in previously treated patients with advanced or metastatic non-squamous NSCLC.  The trial randomised 582 patients to receive either nivolumab 3mg/kg intravenously every two weeks or docetaxel 75mg/m2 intravenously every three weeks. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression free survival. Opdivo is a programmed death-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 (NSCLC) 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 V600mutation positive, a BRAF inhibitor.
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