KEYNOTE-564 — Adjuvant Pembrolizumab Versus Placebo in Renal Cell Carcinoma After Nephrectomy

Phase 3 · 2021 · Renal Cell Carcinoma

Design

Randomized adjuvant pembrolizumab vs placebo for approximately 1 year after nephrectomy.

Population

Resected clear-cell RCC at intermediate-high or high risk of recurrence, or after resection of metastatic disease (M1 NED).

Primary Endpoint

disease-free survival (DFS)

Key Result

5-year analysis: 72-mo OS 86.1% vs 79.4% (HR 0.66); 72-mo DFS 58.5% vs 48.7% (HR 0.71); the only adjuvant RCC therapy to improve overall survival.

Guideline Impact

NCCN category 1 adjuvant pembrolizumab for high-risk resected clear-cell RCC