European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab

Astella Pharma Inc. announced that the European Medicines Agency (EMA) has accepted regulatory review of the company’s Marketing Authorization (MA) Application for zolbetuximab, an experimental first-class monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the first-line treatment of patients with locally advanced, unresectable or metastatic gastric or esophageal adenocarcinoma (GEJ) whose tumor is CLDN18.2 positive count. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for these patients.Stomach cancer accounts for 3.1% of all new cancer cases in Europe in 2020, with around 136,000 newly diagnosed cases.1 Median 5-year survival rate for patients with stomach cancer thickness in Europe is 26% for all periods combined.

“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,”

“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.”

Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas.

The marketing authorization is based on the results of the SPOTLIGHT and GLOW phase 3 clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen consisting of oxaliplatin, leucovorin, and fluorouracil) versus placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen consisting of capecitabine and oxaliplatin) versus placebo plus CAPOX.In the SPOTLIGHT and GLOW studies, approximately 38% of patients screened for the trials had CLDN18.2-positive tumors (≥75% of tumor cells had moderate to CLDN18 membrane staining intensity). strong), as determined by a validated immunohistochemical assay.3,4A tentative recommendation from the EMA’s Committee on Human Medicinal Products (CHMP) regarding marketing authorization and a follow-up decision from the European Commission (EC) is expected in calendar year 2024. .Astellas reflected the impact of this adoption in its financial guidance for the current financial year ending March 31, 2024.