Nivolumab Presents Superior Survival Results in Phase 3 Melanoma Trials

In a press release based off-of results presented at the Society for Melanoma Research 2014 International Congress in Zurich, Switzerland, BMS announced results from phase 3 of the CheckMate-066 trial.

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The New England Journal of Medicine

Bristol-Myers Squibb Company today announced results from CheckMate -066, a phase 3 randomized double blind study, comparing , an investigational PD-1 immune checkpoint inhibitor, to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma (n=418). The study met the primary endpoint of overall survival (OS) with the median OS not reachedfor vs. 10.8 months for DTIC. The one-year survival rate was 73% for vs. 42% for DTIC and there was a 58% decrease in the risk of death for patients treated with (Hazard Ratio for death [HR]: 0.42, P<0.0001). This survival advantage was also observed in -treated patients in both PD-L1 positive and PD-L1 negative patients. Findings from CheckMate -066 were published today in and presented during an oral session at the Society for Melanoma Research 2014 International Congress in Zurich, Switzerland.

New England Journal of Medicine

“The results from CheckMate -066 are significant as they represent the first time a PD-1 immune checkpoint inhibitor has shown a survival benefit in a randomized Phase 3 trial,” said Prof. Caroline Robert, Professor of Dermatology, Head of the Dermatology Unit, Institute Gustave Roussy and lead author of the manuscript. “This represents a major milestone in the study of treatment naïve patients with wild-type BRAF advanced melanoma.”

Link to the complete press release: http://bit.ly/1ycIBUn