The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody.
The application is for authorisation as a 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.
Gastric cancer accounted for 3.1% of all new cancer cases in Europe in 2020, with around 136,000 new cases diagnosed. The average five-year survival rate for patients with gastric cancer in Europe is 26% across all stages.
“Patients with gastric cancer in Europe face extremely low five-year survival rates regardless of their disease stage, and innovative therapies that extend survival are needed,” said Moitreyee Chatterjee-Kishore, Senior Vice President and Head of Immuno-Oncology Development, Astellas. “The EMA’s acceptance of the zolbetuximab MAA continues a cascade of regulatory milestones for Astellas that are aimed at bringing a new option to patients with advanced gastric and GEJ cancer.”
The MAA is based on results from the Phase III SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.
In both SPOTLIGHT and GLOW, approximately 38% of patients screened for the trials had tumours that were CLDN18.2-positive (≥75% of tumour cells with moderate-to-strong membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.
The anticipated recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA regarding the MAA and subsequent European Commission (EC) decision are expected in 2024.