The authors report the 5-year outcomes of this multicenter, double-blind, phase III study of nivolumab versus dacarbazine for the first-line treatment of 418 patients with unresectable stage III/IV, wild-type BRAF melanoma. Benefits for overall survival, progression-free survival, and objective response rate with nivolumab were confirmed. The 5-year overall survival rate was 39% with nivolumab. Among 75 nivolumab-treated patients followed to 5 years, 45 had discontinued nivolumab and had not received subsequent systemic therapy.
These updated results confirm the long-term survival and durable responses associated with nivolumab in patients with metastatic melanoma.
Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.