Administered with or without ipilimumab, adjuvant nivolumab improved recurrence-free survival in patients with stage IV melanoma with no evidence of disease who were at high risk of recurrence, and overall survival was improved with both agents, according to results of the IMMUNED phase 2 trial.
“Use of subsequent anti-PD-1-based therapy was high in patients in the placebo group after recurrence and most likely impacted the overall survival comparison of nivolumab alone versus placebo,” the authors conclude. “The recurrence-free and overall survival benefit of nivolumab plus ipilimumab over placebo reinforces the change of practice already initiated for the treatment of patients with stage IV melanoma with no evidence of disease.”
Participants were randomized to either nivolumab plus ipilimumab (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks), nivolumab monotherapy (nivolumab 3 mg/kg every 2 weeks), or matching placebo, for up to 1 year. Compared with placebo, hazard ratios (HRs) for risk of recurrence were significant at 0.25 for nivolumab plus ipilimumab and 0.60 for nivolumab alone. For overall survival, the HR was 0.41 for nivolumab plus ipilimumab group versus placebo, a significant reduction, and a nonsignificant 0.75 for nivolumab versus placebo. Four-year survival rates were 83.8% in the nivolumab plus ipilimumab group, 72.6% in the nivolumab alone group, and 63.1% in the placebo group.