Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
Level 2 - randomized trial
Individual randomized controlled trial with long-term follow-up
PubMed 31562797 · doi:10.1056/NEJMoa1910836
What was done
Patients with previously untreated advanced melanoma were randomly assigned to one of three arms: nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) every 3 weeks for four doses followed by nivolumab (3 mg/kg every 2 weeks); nivolumab monotherapy (3 mg/kg every 2 weeks) plus matched placebo; or ipilimumab monotherapy (3 mg/kg every 3 weeks for four doses) plus matched placebo. Co-primary endpoints were progression-free survival and overall survival. Outcomes at a minimum follow-up of 60 months were evaluated.
What was found
Median overall survival was >60.0 months (not reached) with nivolumab plus ipilimumab and 36.9 months with nivolumab alone, compared with 19.9 months with ipilimumab alone. The hazard ratio for death compared to ipilimumab was 0.52 for nivolumab plus ipilimumab and 0.63 for nivolumab monotherapy. Five-year overall survival rates were 52% for nivolumab plus ipilimumab, 44% for nivolumab alone, and 26% for ipilimumab alone. No sustained deterioration of health-related quality of life and no new late toxic effects were observed.
Why it matters
This study demonstrates durable five-year survival for first-line checkpoint inhibitor regimens in advanced melanoma, with more than half of patients receiving combined nivolumab and ipilimumab surviving at five years.
Limits
The abstract does not state the total sample size (n), confidence intervals for hazard ratios, or the specific incidence of adverse events. Industry sponsorship is noted.