MRV Research

Phase 3 First-Line Melanoma Study of Nivolumab, an Investigational PD-1 Checkpoint Inhibitor, Demonstrates Superior Overall Survival Compared to Dacarbazine; Study Stopped Early

Bristol-Myers Squibb Company today announced that a randomized blinded comparative Phase 3 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 Company will share these data with health authorities.

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Ipilimumab in advanced melanoma: Added benefit for non-pretreated patients not proven

In early 2014, the German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ipilimumab in non-pretreated patients with advanced melanoma. The drug manufacturer claimed a noticeable increase in survival time and thus an added benefit versus dacarbazine, the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). However, the indirect comparison conducted by the company was too uncertain, and the postulated effect was biased in favour of ipilimumab. Hence an added benefit was not proven.

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