Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) in China has accepted the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody (mAb), for the 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 become the first CLDN18.2-targeted therapy available in China for these patients.
Phase III Clinical Trials Support BLA Submission
The BLA submission is supported by the results from the Phase III GLOW and SPOTLIGHT clinical trials. The GLOW study compared zolbetuximab plus CAPOX (capecitabine and oxaliplatin) to placebo plus CAPOX. In the GLOW study, involving 145 patients randomized in mainland China, the combination of zolbetuximab and CAPOX reduced the risk of disease progression or death by 31.3% (HR=0.687; P=0.0007), meeting the primary endpoint. The median progression-free survival for the treatment group was 8.21 months compared to 6.80 months for the placebo group. In terms of key secondary endpoints, the combination significantly prolonged overall survival (OS) and reduced the risk of death by 22.9% (HR=0.771; P=0.0118), with median OS at 14.39 months and 12.16 months respectively.
SPOTLIGHT Study Results
The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6. With 36 patients randomized in mainland China, the study showed that the combination reduced the risk of disease progression or death by 24.9% (P=0.0066), with a median PFS of 10.61 months compared to 8.67 months for the placebo group. The SPOTLIGHT study also observed the longest median OS in the Phase III study of this patient population.-Fineline Info & Tech
