The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted Astellas Pharma’s biologics licence application (BLA) for the investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, zolbetuximab.

Zolbetuximab is intended for treating patients with HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive.

The application is based on data from the Phase III GLOW and SPOTLIGHT clinical trials that assessed zolbetuximab along with other therapies.

The GLOW study evaluated the therapy and CAPOX (a combination chemotherapy including capecitabine and oxaliplatin) against CAPOX and placebo.

SPOTLIGHT assessed zolbetuximab along with mFOLFOX6 (a combination regimen including oxaliplatin, leucovorin and fluorouracil) against mFOLFOX6 and placebo.

A total of 145 patients, and 36 from mainland China, were enrolled for the GLOW and SPOTLIGHT studies.

The primary endpoint of both studies is progression-free survival (PFS). Safety, tolerability, quality-of-life parameters, overall survival, objective response rate and duration of response are their secondary endpoints.

Astellas Immuno-Oncology Development head and senior vice-president Moitreyee Chatterjee-Kishore stated: “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.”

An open-label, multi-centre, randomised Phase II study for treating patients with metastatic pancreatic adenocarcinoma with CLDN18.2-positive tumours is currently underway.

The study intends to assess zolbetuximab along with gemcitabine plus nab-paclitaxel as a first-line treatment.