Dr. Atkins on Long-Term Survival Benefit of Nivolumab/Ipilimumab in Advanced Melanoma

Michael B. Atkins, MD, deputy director, Georgetown-Lombardi Comprehensive Cancer Center, discusses data from a phase I trial exploring the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) in patients with melanoma.

The phase I CA209-004 trial, the first to explore the combination of an anti—CTLA-4 checkpoint inhibitor and an anti­–PD-1 inhibitor, was initially reported at the 2013 ASCO Annual Meeting and was subsequently published in the New England Journal of Medicine, says Atkins. For the trial, investigators looked at 5 different concurrent dosing cohorts with various schedules of the 2 agents over a maximum of 2 years.

Results presented at that time showed a favorable response rate at 53%; these data led to both randomized phase II and phase III trials that compared the combination with either single-agent ipilimumab or single-agent ipilimumab and nivolumab, says Atkins. Following the results from these trials, the combination was approved as a preferred treatment in metastatic melanoma.

At 3 years, 63% of the first patients who were treated with the combination were alive, and the median overall survival (OS) was about 22 months. Final OS data and outcomes of patients who have discontinued treatment were reported at the 2019 ASCO Annual Meeting. Results showed that 57% of patients are alive at 4 years, says Atkins. More remarkably, each of the 5 cohorts had a favorable survival rate of at least 49%, he adds.