Alexander M. Eggermont, MD, PhD, discusses the results of the KEYNOTE 054 trial of pembrolizumab versus placebo in patients with high-risk stage III melanoma after a complete resection.
Alexander M. Eggermont, MD, PhD, professor of Oncological Surgery and general director of Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, discusses the results of the KEYNOTE 054 trial of pembrolizumab (Keytruda) versus placebo in patients with high-risk stage III melanoma after a complete resection.
In this phase 3 trial, the investigators reported more mature data on recurrence-free survival (RFS), with a median follow-up of 3 years. Eggermont says the question is whether the results are demonstrating sustainability in terms of impact on RFS, and the results confirmed this is true. The important data in this study for years 1, 2, and 3 were RFS rates.
At 1 year, the difference in RFS rates for the pembrolizumab arm and the placebo arm was 15%; at 2 years, the difference was 20%; and at 3 years, it was still about 20%. The RFS benefit was sustained at year 2 and year 3 at 20% for the absolute difference between the 2 arms, with a 63.7% RFS rate for patients receiving pembrolizumab compared with 44.1% for the patients receiving placebo. These results are reassuring but also not surprising since this is what is expected with checkpoint inhibitors, Eggermont says.