Dr. Luke on the Results of the Phase 3 KEYNOTE-716 Trial in Melanoma

Jason J. Luke, MD, FACP, director, Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, associate professor of medicine, Division of Hematology/Oncology, University of Pittsburgh School of Medicine, discusses the results of the phase 3 KEYNOTE-716 trial (NCT03553836) in high-risk stage II melanoma.

The double-blind trial evaluated the safety and efficacy of pembrolizumab (Keytruda) after complete resection in patients with high-risk stage II melanoma. The results of the study, which were presented during the 2021 ESMO Congress, demonstrated that the trial met its prespecified efficacy analyses during the first assessment, Luke says. Moreover, the hazard ratio for recurrence-free survival was 0.65, translating to a 35% reduction in the risk of recurrence in patients with stage IIB and IIC disease, Luke explains. An additional key finding in the study was that treatment with pembrolizumab reduced the incidence of distant metastases by approximately 40%, Luke adds.

No unexpected efficacy signals were observed with pembrolizumab, as it is a well-known drug, and no new safety signals were noted, Luke continues. The quality-of-life assessment was overlapping and nearly identical between the pembrolizumab and placebo arms at evaluable time points, Luke concludes.