Nivolumab with or without ipilimumab has shown long-lasting survival outcomes as a first-line treatment for patients with advanced melanoma in the phase 3 CheckMate 067 trial, with results published in Lancet Oncology.
In this study, 945 treatment-naïve patients with stage III or IV melanoma and known BRAFV600mutation status were randomly assigned to receive nivolumab alone (316 patients), ipilimumab (315 patients), or the combination (nivolumab plus ipilimumab; 314 patients). Primary end points were overall survival and progression-free survival.
Nivolumab alone or with ipilimumab outperformed ipilimumab alone for both end points. Median overall survival was 36.9 months (95% CI, 28.3-not reached) for the nivolumab group, 19.9 months (95% CI, 16.9-24.6) for the ipilimumab group, and not reached (95% CI, 38.2 months-not reached) for the combination group.
Median progression-free survival for the nivolumab group was 6.9 months (95% CI, 5.1-10.2), 2.9 months (95% CI, 2.8-3.2) for the ipilimumab group, and 11.5 months (95% CI, 8.7-19.3) for the combination group.
Four treatment-related deaths occurred: neutropenia in the nivolumab group (1 patient), colon perforation in the ipilimumab group (1 patient), and one patient each from liver necrosis and cardiomyopathy in the combination treatment.
Grade 3-4 treatment-related adverse events (TRAEs) occurred in 22% of patients in the nivolumab cohort, 28% in the ipilimumab group, and 59% in the combination group. The most common grade 3 TRAEs were diarrhea in both the nivolumab and combination groups, and colitis in the ipilimumab group, and increased lipase was the most common grade 4 TRAE in all groups.
Nivolumab alone or with ipilimumab showed good long-term efficacy against advanced melanoma, the authors concluded.
Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial[published online October 22, 2018]. Lancet Oncol. doi: 10.1016/S1470-2045(18)30700-9