Roche Secures CE Mark for New Companion Diagnostic
The Basel, Switzerland-based company said the assay could identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with Vyloy.
October 10, 2024
Roche has obtained CE mark approval for a companion diagnostic to identify patients with gastric and gastroesophageal junction cancer. The patients identified with the VENTANA CLDN18 (43-14A) RxDx Assay could be eligible for targeted treatment with Astellas’ Vyloy.
The Basel, Switzerland-based company’s test determines CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. The test measures expression of both variants of the CLDN18 protein (18.1 and 18.2 isoforms). CLDN18.2 is the predominant variant expressed in gastric and GEJ cancers.
Astella’s Vyloy is a monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker CLDN18.2. The Tokyo, Japan-based company won CE mark approval for the therapy in September.
“Gastric cancer remains a significant global health challenge. In Europe, only three percent of patients with metastatic disease live beyond five years," said Matt Sause, CEO of Roche Diagnostics. "Our new companion diagnostic is a significant step forward for patients. By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities, and aid clinicians to potentially improve outcomes.”
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on the results of the SPOTLIGHT and GLOW clinical studies where it was used as the enrollment assay to identify patients whose tumors were CLDN18.2 positive. CLDN18.2 positivity is defined as ≥ 75% of tumor cells demonstrating moderate to strong membrane CLDN18 staining as measured by the VENTANA CLDN18 (43-14A) RxDx Assay.
In these studies, about 38% of gastric/GEJ cancer patients expressed high levels of CLDN18 and were considered CLDN18.2 positive by the VENTANA CLDN18 (43-14A) RxDx Assay. Patients who received a combination of zolbetuximab and chemotherapy experienced a 25% -31% reduction in disease progression or death.
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