KEYNOTE-590 — Pembrolizumab Plus Chemotherapy for Advanced Esophageal and Gastroesophageal Junction Cancer

Phase 3 · 2021 · Esophageal Cancer

Design

Randomized cisplatin plus 5-FU with pembrolizumab or placebo.

Population

Untreated advanced esophageal squamous cell carcinoma or adenocarcinoma and GEJ adenocarcinoma.

Primary Endpoint

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

Key Result

OS 12.4 vs 9.8 mo overall (HR 0.73); greatest benefit in ESCC with PD-L1 CPS >=10 (OS HR 0.57).

Guideline Impact

NCCN category 1 first-line for advanced esophageal/GEJ cancer (CPS-dependent)