Abstract
The claudin 18 (CLDN18) protein has two isoforms: CLDN18.1 and CLDN18.2. Nonclinical studies have shown that CLDN18.2 is the dominant isoform of CLDN18 expressed in gastric adenocarcinoma (GA) and pancreatic adenocarcinoma (PA); thus, CLDN18.2 has emerged as a promising targetable biomarker. Zolbetuximab, a chimeric IgG1 monoclonal antibody, binds specifically to CLDN18.2 and mediates cancer cell death via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. The phase 2 FAST study enrolled CLDN18.2-positive (based on IHC testing) patients with gastric or gastroesophageal junction adenocarcinoma (NCT01630083); in this study, patients who received zolbetuximab+EOX (epirubicin, oxaliplatin, capecitabine) versus EOX alone experienced prolonged survival.
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