TOKYO, July 31, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics 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 tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in China for these patients.
Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas
“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.”
The BLA is based on results from the Phase 3 GLOW and SPOTLIGHT clinical trials. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX. In the GLOW study, 145 patients were randomized in mainland China. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. In the SPOTLIGHT study, 36 patients were randomized in mainland China.
In both GLOW and SPOTLIGHT, approximately 38% of patients screened for the trials had tumors that were CLDN18.2-positive (≥75% of tumor cells with moderate-to-strong membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.1,2
Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2024.
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