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Roche’s VENTANA CLDN18 (43-14A) RxDx Assay for Identifying Gastric and GEJ Cancer Patients Receives CE Mark Approval

NextEdge Admin

11 Oct 2024

2 min 25 sec

Roche has announced that its VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for assessing CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. This test enables the identification of patients who may be eligible for Astellas’ targeted therapy, VYLOY (zolbetuximab).

“Gastric cancer is a major global health issue, with only three percent of metastatic patients in Europe surviving beyond five years,” said Matt Sause, CEO of Roche Diagnostics. The new companion diagnostic is a significant advancement, as it helps clinicians identify patients who may benefit from targeted treatments, potentially improving outcomes.

Current guidelines emphasize using biomarkers to inform treatment decisions for gastric/GEJ cancer. The VENTANA CLDN18 (43-14A) RxDx Assay evaluates CLDN18.2 status, providing essential information for clinicians regarding the suitability of CLDN18.2 targeted therapies. VYLOY is the first treatment approved for CLDN18.2-positive gastric/GEJ cancer, offering more tailored options for patients.

Gastric cancer is the fifth most common cancer globally, with high incidence rates in Central and Eastern Europe. Often diagnosed late, it has an overall survival rate of just 25% in the EU. The VENTANA assay measures both CLDN18.1 and CLDN18.2 isoforms, with the latter being predominantly expressed in gastric and GEJ cancers. Approval of the assay is based on results from the SPOTLIGHT and GLOW studies, which showed that approximately 38% of patients had high levels of CLDN18, benefiting from the combination of zolbetuximab and chemotherapy.