Clear survival benefit for B-MS' Opdivo in advanced melanoma patients
US drug major Bristol-Myers Squibb (NYSE: BMY) has announced positive results from a study comparing Opdivo (nivolumab) to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.
The Phase III randomized double blind CheckMate -066 study met the primary endpoint of overall survival (OS) with the median OS not reached for Opdivo versus 10.8 months for DTIC. The one-year survival rate was 73% for Opdivo vs 42% for DTIC and there was a 58% decrease in the risk of death for patients treated with Opdivo (Hazard Ratio for death [HR]: 0.42, P<0.0001). This survival advantage was also observed in Opdivo-treated patients in both PD-L1 positive and PD-L1 negative patients.
The results were published yesterday in The New England Journal of Medicine and presented at the Society for Melanoma Research 2014 International Congress in Zurich, Switzerland.
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