SPOTLIGHT — Zolbetuximab Plus mFOLFOX6 in Claudin-18.2-Positive, HER2-Negative Advanced Gastric or GEJ Adenocarcinoma (SPOTLIGHT)

Phase 3 · 2023 · Gastric Cancer, Gastroesophageal Junction Cancer

Design

Randomized double-blind trial of zolbetuximab plus mFOLFOX6 versus placebo plus mFOLFOX6.

Population

Untreated claudin-18.2-positive, HER2-negative locally advanced or metastatic gastric or GEJ adenocarcinoma.

Primary Endpoint

progression-free survival (PFS)

Key Result

PFS 10.6 vs 8.7 months (HR 0.75) and overall survival 18.2 vs 15.5 months (HR 0.75).

Guideline Impact

NCCN-listed zolbetuximab plus mFOLFOX6 for first-line CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma