Patients with advanced melanoma may experience significantly prolonged overall survival (OS) when treated with nivolumab plus ipilimumab compared with nivolumab or ipilimumab alone, according to a study published in The New England Journal of Medicine.

For the phase 3 Checkmate 067 study, researchers assigned patients with advanced melanoma 1:1:1 to receive nivolumab 3 mg/kg plus placebo, ipilimumab 3 mg/kg plus placebo, or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg followed by nivolumab 3 mg/kg. Patients were stratified according to programmed death ligand 1 (PDL-1) status, melanomaBRAF mutation status, and metastasis stage.

Median overall survival was not reached by patients in the nivolumab-plus-ipilimumab arm at the minimum follow-up of 36 months, and was 37.6 months among patients in the nivolumab group and 19.9 months among patients in the ipilimumab group (hazard ratio [HR] for death with nivolumab plus ipilimumab vs ipilimumab, 0.55 [P <.001]; HR for death with nivolumab vs ipilimumab, 0.65 [P <.001]).

The overall survival rate at 3 years was 58%, 52%, and 34% in the nivolumab-plus-ipilimumab, nivolumab, and ipilimumab groups, respectively.

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The safety profiles of the study medications remained consistent with those of previous findings, and grade 3 to 4 adverse events occurred in 59%, 21%, and 28% in the nivolumab-plus-ipilimumab, nivolumab, and ipilimumab groups, respectively.

The authors of the study concluded that “long-term survival outcomes occurred with nivolumab plus ipilimumab combination therapy and with nivolumab alone in patients with previously untreated advanced melanoma. Survival outcomes with either nivolumab-containing regimen were superior to those with ipilimumab alone.”

Reference

1. Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma [published online September 11, 2017]. N Eng J Med. doi: 10.1056/NEJMoa1709684