European Approval of the World's First CLDN18.2 Targeted Therapy

Astellas Pharma (4503.T)'s first-in-class antibody drug Vyloy (active ingredient: zolbetuximab) has obtained final marketing authorization from the European Commission (EC). This approval is indicated for the first-line treatment of adult patients with locally advanced, unresectable, or metastatic CLDN18.2-positive, HER2-negative adenocarcinoma of the stomach and gastroesophageal junction (GEJ). This official decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) two months ago, and is evaluated as a key outcome of the mega-deal in 2016 where Astellas acquired Ganymed for 1.28 billion euros.

Survival Improvement Through Large-Scale Phase 3 Clinical Trials (SPOTLIGHT and GLOW)

In the global phase 3 SPOTLIGHT trial, which served as the basis for approval, the combination of biliary acid therapy with mFOLFOX6 significantly reduced the risk of death by 25% compared to the placebo group, with a median progression-free survival (mPFS) of 10.61 months versus 8.67 months (HR 0.75, p=0.0066) and a median overall survival (mOS) of 18.23 months versus 15.54 months (HR 0.75, p=0.0053). The GLOW phase 3 trial, which employed a different combination chemotherapy regimen, also demonstrated consistent survival benefits, with the bevacizumab plus CAPOX arm achieving an mPFS of 8.21 months versus 6.80 months (HR 0.687, p=0.0007) and an mOS of 14.39 months versus 12.16 months (HR 0.771, p=0.0118). In the first-line treatment setting for advanced gastric cancer, which had relied solely on toxic chemotherapy, we established a new standard of care that significantly extends survival time after more than a decade.

Precision Medicine Paradigm and Target Population Capture in HER2-Negative Gastric Cancer

Since approximately 38% of all gastric and gastroesophageal junction adenocarcinomas are classified as CLDN18.2-positive, BioAge has captured a significant unmet medical demand. It presents a viable targeted therapy alternative for the majority of patient groups who previously did not benefit from the existing HER2-positive targeted therapy Herceptin (Herceptin), as well as for patients whose treatment with immune checkpoint inhibitors as monotherapy or in combination was limited. The approval of Roche's VENTANA CLDN18 RxDx companion diagnostic (CDx) device is expected to rapidly establish a biomarker selection system based on precision oncology in European clinical settings.

Leap Toward Blockbuster Status and Securing Global Commercial Competitiveness

Following the PMDA approval in Japan in March 2024, this European approval, along with the US FDA approval in October, serves as a bridgehead to dominate all three major global pharmaceutical markets. Astellas has positioned Xtandi as a next-generation pipeline to fill the patent expiration gap of its flagship drug, projecting peak annual sales of 100 billion to 200 billion yen (approximately $700 million to $1.4 billion). Considering that CLDN18.2 ADCs from latecomers such as AstraZeneca (AZD0901) and BMS (BMS-986504) are in early clinical stages, Vyloy is positioned to secure a dominant market position by leveraging its first-mover advantage and real-world evidence (RWE).