Astellas Pharma Inc. announced positive topline results from the phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in combination with Capox (a combination chemotherapy regimen that includes capecitabine and oxaliplatin).
Zolbetuximab is an investigational first-in-class Claudin-18.2 (CLDN18.2) targeted monoclonal antibody, for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The GLOW study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus Capox compared to placebo plus Capox. In addition, the study met a key secondary endpoint, overall survival (OS), showing statistical significance for patients treated with zolbetuximab plus Capox compared to placebo plus Capox. The most frequent treatment-emergent adverse events (TEAEs) were nausea and vomiting. Detailed results will be presented at a future scientific congress and submitted for publication.
