The phase 3 KEYNOTE-564 trial has demonstrated a significant overall survival (OS) benefit with pembrolizumab in patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence following surgery. This landmark study, a global, placebo-controlled trial, marks a crucial advancement by bringing PD-1 inhibition into the adjuvant setting, fundamentally changing the approach to managing this disease.
The trial enrolled patients with ccRCC who were at high risk for disease recurrence after complete resection of their primary tumors, with or without resectable metastatic sites. Participants were randomly assigned to receive either pembrolizumab or placebo for up to one year, following a double-blind design. The study was stratified for risk factors and geographic areas to ensure a comprehensive evaluation across diverse populations.
The KEYNOTE-564 trial met its primary endpoint of disease-free survival. Subsequent analysis, after a median follow-up of 57.2 months, confirmed a statistically significant OS benefit with pembrolizumab compared to placebo, as published in The New England Journal of Medicine in April 2024. According to Dr. Martin H. Voss, Memorial Sloan Kettering Cancer Center, the study reported a 5.2% improvement in OS with pembrolizumab versus placebo.
"This trial is the only study of a PD-1 inhibitor to show an OS benefit compared with placebo in the adjuvant setting for kidney cancer," Dr. Voss noted. This breakthrough has had ripple effects across the oncology field, influencing discussions and shaping clinical practice on a global scale.
The KEYNOTE-564 trial's findings establish pembrolizumab as a significant treatment option, offering improved overall survival for patients with ccRCC at high risk of recurrence following surgery.
