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Many patients with renal cell carcinoma (RCC) who undergo surgery with curative intent have a high risk of disease recurrence and until recently no palatable adjuvant systemic therapy options. Blocking the programmed death ligand (PD-1) immune checkpoint pathway with pembrolizumab has robust clinical efficacy in patients with metastatic RCC. Results from the KEYNOTE 564 trial demonstrate that adjuvant pembrolizumab significantly improves disease- free survival after nephrectomy or metastasectomy. We provide an overview of efforts to develop an adjuvant therapy in patients with high-risk RCC. This includes a critical review of efficacy, toxicity, and clinical implications from a large phase III trial leading to the FDA and EMA approvals of adjuvant pembrolizumab. Pembrolizumab offers an effective and well-tolerated adjuvant therapy for patients with surgically resected RCC at high-risk of disease recurrence. Future research will focus on optimal patient selection and biomarkers that predict benefit and/or toxicity from therapy.

Adjuvant therapy for patients with renal cell carcinoma following surgery: a focus on pembrolizumab