Overall Survival in Advanced Melanoma Improved With Nivolumab, Ipilimumab Combination
Survival outcomes were observed when a combination therapy was employed to treat advanced melanoma, researchers found.
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.
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.”
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