Bristol-Myers Ph III nivolumab trial stopped early on good results

25 June 2014
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Shares of US pharma major Bristol-Myers Squibb (NYSE: BMY) rose 2.6% to $49.55 in post-market trading on June 25, after the company halted a clinical trial with its investigational melanoma drug nivolumab due to good results.

B-MS announced that a randomized blinded comparative Phase III study evaluating nivolumab versus dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee (DMC) showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab.

“The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase III trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, head of oncology development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival,” he added.

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