CheckMate 649 — Nivolumab Plus Chemotherapy or Ipilimumab Versus Chemotherapy in Previously Untreated Advanced Gastric, GEJ, and Esophageal Adenocarcinoma

Phase 3 · 2021 · Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

Design

Randomized trial of first-line nivolumab plus chemotherapy versus chemotherapy alone (with a nivolumab/ipilimumab arm) in advanced gastric/GEJ/esophageal adenocarcinoma.

Population

Untreated, HER2-negative advanced gastric, GEJ, or esophageal adenocarcinoma.

Primary Endpoint

overall survival (OS) and progression-free survival (PFS) in PD-L1 CPS >=5

Key Result

In CPS >=5, median OS 14.4 vs 11.1 months (HR 0.71); benefit in all randomized patients (HR 0.80).

Guideline Impact

NCCN category 1 first-line for HER2-negative gastric/GEJ adenocarcinoma