Adjuvant pembrolizumab versus placebo for renal cell carcinoma: overall survival results of the multinational phase 3 KEYNOTE-564 trial

Adjuvant pembrolizumab therapy after surgery for renal cell carcinoma (RCC) was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial. Overall survival results of the trial have now been published. Patients with clear-cell RCC who had an increased risk of recurrence after surgery were randomized 1:1 to adjuvant pembrolizumab (200 mg) or placebo every 3 weeks for up to 17 cycles or until recurrence, occurrence of unacceptable toxic effects, or withdrawal of consent. The median follow-up was 57.2 months. Overall survival rate at 48 months was 91.2% in the pembrolizumab group and 86.0% in the placebo group (HR 0.62; p=0.005). Pembrolizumab was associated with a higher incidence of serious adverse events of any cause (20.7%, versus 11.5% with placebo) and of grade 3 or 4 treatment-related adverse events (18.6% versus 1.2%). No deaths were attributed to pembrolizumab therapy. The authors conclude that among patients with clear-cell RCC at increased risk for recurrence after surgery, adjuvant pembrolizumab, as compared with placebo, was associated with a significant and clinically meaningful improvement in overall survival (quick take video summary).