Jedd D. Wolchok, MD, PhD, from the Memorial Sloan-Kettering Cancer Center, discusses a phase I trial exploring the combination of the anti-PD-1 antibody nivolumab and ipilimumab, a CTLA-4 inhibitor, for patients with advanced melanoma.
Jedd D. Wolchok, MD, PhD, a medical oncologist at Memorial Sloan-Kettering Cancer Center in New York, discusses a phase I trial exploring the combination of the anti-PD-1 antibody nivolumab and ipilimumab, a CTLA-4 inhibitor, for patients with advanced melanoma.
Ipilimumab was approved by the FDA to treat metastatic melanoma in 2011 based on the phase III demonstration of an extension in survival. Additionally, a phase I trial showed that nivolumab was capable of effectively eliciting durable clinical responses. These data, and other research, led to the phase I trial exploring the combination.
In the trial, the overall response rate in the concurrent treatment cohorts was 40%. Additionally, Wolchok notes, a significant number of patients experienced rapid and deep regressions with 80% showing signs of a reduction in tumor burden after 12 weeks of treatment. Patients receiving the highest dose (1 mg/kg of nivolumab and 3 mg/kg of ipilimumab) experienced an objective response rate of 53% with 18% demonstrating a complete response.
This early phase trial demonstrated significant activity for the combination of ipilimumab and nivolumab. Based on this data, Wolchok notes, a phase III trial has been launched comparing the combination to single agent nivolumab or ipilimumab.