Today on 1st August 2023, Astellas Pharma (TSE:4503) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the biological license application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted medication for these patients to be made available in China.
Results from the Phase III GLOW and SPOTLIGHT clinical studies served as the foundation for the BLA. In the GLOW study, capecitabine and oxaliplatin-containing chemotherapy combination therapy (CAPOX) was compared to placebo-plus-CAPOX. 145 individuals were randomly assigned in mainland China for the GLOW research. The combination of zolbetuximab with mFOLFOX6 (which also contains oxaliplatin, leucovorin, and fluorouracil) was compared to a placebo plus mFOLFOX6 in the SPOTLIGHT study. In the SPOTLIGHT research, 36 individuals are randomized in mainland China.
According to a validated immuno-histochemical assay, 38% of patients screened for the trials in GLOW and SPOTLIGHT had tumours that were CLDN18.2-positive (75% of tumour cells with moderate-to-strong membranous CLDN18 staining intensity).
“China accounts for nearly half of the world’s new cases of gastric cancer, with more than 478,000 new cases diagnosed and more than 373,000 deaths in 2020. The CDE’s acceptance of our BLA for zolbetuximab brings us one step closer to having a new therapy available for Chinese patients with advanced-stage disease and in need of treatment options.”-Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas
