KEYNOTE-811 — Pembrolizumab Plus Trastuzumab and Chemotherapy for HER2-Positive Advanced Gastric or GEJ Adenocarcinoma

Phase 3 · 2023 · Gastric Cancer

Design

Randomized trastuzumab plus chemotherapy with pembrolizumab or placebo.

Population

Untreated HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Primary Endpoint

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

Key Result

Final analysis: ITT OS 20.0 vs 16.8 mo (HR 0.80, P=0.004); in CPS >=1, OS 20.1 vs 15.7 mo (HR 0.79) and PFS 10.9 vs 7.3 mo (HR 0.72).

Guideline Impact

NCCN-recommended first-line pembrolizumab with trastuzumab and chemotherapy for HER2-positive CPS >=1 gastric/GEJ cancer