Thirty-month follow-up of adjuvant pembrolizumab post-nephrectomy for high-risk clear cell renal cell carcinoma

The multinational phase 3 KEYNOTE-564 trial randomized patient with clear cell renal cell carcinoma and increased risk of recurrence after nephrectomy to 17 three-week cycles of adjuvant pembrolizumab 200 mg or placebo. After median 30.1 months of follow-up, the disease-free survival was better with pembrolizumab compared to placebo (HR 0.63; 95% CI 0.50-0,80). This DFS advantage was seen in most subgroups. No deaths were attributed to pembrolizumab. The authors conclude that these results support the use of adjuvant pembrolizumab monotherapy as a standard of care for patients with renal cell carcinoma with an increased risk of recurrence after nephrectomy.