KEYNOTE-045 — Pembrolizumab Versus Chemotherapy for Advanced Urothelial Carcinoma After Platinum Therapy

Phase 3 · 2017 · Bladder Cancer

Design

Randomized pembrolizumab vs investigator-choice chemotherapy (paclitaxel, docetaxel, or vinflunine).

Population

Advanced urothelial carcinoma that recurred/progressed after platinum-based chemotherapy.

Primary Endpoint

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

Key Result

OS 10.3 vs 7.4 mo (HR 0.73); durable responses with fewer high-grade toxicities than chemotherapy.

Guideline Impact

NCCN category 1 second-line pembrolizumab for advanced urothelial carcinoma