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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).
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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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