KEYNOTE-426 — Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Axitinib Versus Sunitinib Monotherapy as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma

Phase 3 · 2019 · Renal Cell Carcinoma

Design

Randomized trial of pembrolizumab plus axitinib vs. sunitinib as first-line therapy.

Population

Previously untreated advanced/metastatic clear-cell RCC across all IMDC risk groups.

Primary Endpoint

overall survival (OS) and progression-free survival (PFS)

Key Result

12-mo OS 90% vs 78%; HR for death 0.53; median PFS 15.1 vs 11.1 mo (HR 0.69); ORR 59% vs 36%.

Guideline Impact

NCCN preferred first-line for advanced clear-cell RCC