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FDA Approves Nivolumab/Ipilimumab Combination for BRAF Wild-Type Melanoma

Dr. Jedd D. Wolchok

Jedd D. Wolchok, MD, PhD

The FDA has granted an accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a treatment for patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma, based on findings from the phase II CheckMate-069 study.

In the phase II study, the PD-1 inhibitor nivolumab plus CTLA-4 inhibitor ipilimumab reduced the risk of progression or death by 60% compared ipilimumab alone (HR, 0.40; 95% CI, 0.22-0.71; P <.002). With the combination, the objective response rate (ORR) was 60% compared with 11% with ipilimumab alone in patients with BRAF WT melanoma. Additionally, the complete response rate with the combination was 17% versus none with monotherapy. Click here to read the full article at


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