Opdivo Achieves Primary Endpoint in Melanoma Trial
Bristol-Myers Squibb Company announced results from the Phase 3 CheckMate-066 study comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.
CheckMate -066 IS a Phase 3 randomized, double-blind study in which 418 patients with naïve BRAF wild-type unresectable Stage 3 and 4 melanoma were randomized to either Opdivo or DTIC. Treatment was continued until there was disease progression or an unacceptable level of toxicity. The primary endpoint was overall survival (OS).
The study met the primary endpoint of OS with the median OS not reached for Opdivo vs. 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 (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.
On June 24, 2014, CheckMate -066 was stopped early because an analysis demonstrated evidence of superior OS in patients receiving Opdivo compared to the control arm, DTIC. As a result, patients in the trial were unblinded and allowed to receive Opdivo.
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