Outcomes derived from the final analysis of the KEYNOTE-006 study show that after nearly 2 years of follow-up, pembrolizumab continues to demonstrate significant superiority over ipilimumab for the treatment of patients with advanced melanoma. The results were published in the Lancet.
Patients from 87 academic institutions, hospitals, and cancer centers in 16 different countries were recruited for the study. A total of 834 participants with advanced melanoma were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment regimens: (1) intravenous (IV) pembrolizumab 10 mg/kg every 2 weeks (n=279); (2) IV pembrolizumab 10 mg/kg every 3 weeks (n=277); or (3) IV ipilimumab 3 mg/kg every 3 weeks for 4 doses (n=278). Overall, 1 patient in the pembrolizumab 2-week arm and 22 individuals in the ipilimumab arm withdrew consent and were not treated, leaving a total of 811 participants who received ≥1 dose of study medication.
Eligible patients were ≥18 years of age, had an Eastern Cooperative Performance Status of 0 or 1, and had ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors version 1.1. Median follow-up was 22.9 months. A total of 383 patients died over the course of the study.
Median overall survival was not achieved in either of the pembrolizumab groups and was 16 months in the ipilimumab group (hazard ratio [HR] 0.68; 95% CI, 0.53-0.87 with pembrolizumab every 2 weeks vs ipilimumab; P =.0099 and HR 0.68; 95% CI, 0.53-0.86 with pembrolizumab every 3 weeks vs ipilimumab; P =.0008). The 24-month overall survival rates were 55% in the pembrolizumab 2-week arm, 55% in the pembrolizumab 3-week arm, and 43% in the ipilimumab arm. Long-term treatment with pembrolizumab was shown to be well tolerated and efficacious.
The investigators concluded that pembrolizumab provides a favorable risk-benefit profile compared with ipilimumab, supporting its continued use as standard care for patients with advanced melanoma.
Schachter J, Ribas A, Long GV, et al. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017;390(10105):1853-1862.