NEW YORK – Roche announced on Thursday that its Ventana CLDN18 (43-14A) RxDx assay has received CE marking for use in patients with gastric or gastroesophageal junction (GEJ) cancer who may be eligible for treatment with Astellas Pharma's Vyloy (zolbetuximab).
The immunohistochemical test determines Claudin 18 protein expression in tumors of patients with gastric or GEJ adenocarcinoma. It uses the OptiView DAB IHC Detection Kit for staining on a BenchMark Ultra instrument, Roche said in a statement, adding the assay measures expression of both variants of the CLDN18 protein.
"Gastric cancer remains a significant global health challenge," Roche Diagnostics CEO Matt Sause said. "In Europe, only 3 percent of patients with metastatic disease live beyond five years."
"By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities and aid clinicians to potentially improve outcomes," Sause added.
The test's CE approval was based on the results of the SPOTLIGHT and GLOW studies, where it was used as the enrollment test to identify patients with CLDN18.2-positive tumors. In the studies, about 38 percent of patients were considered CLDN18.2 positive. Patients who received a combination of Vyloy and chemotherapy saw a 25 percent to 31 percent reduction in disease progression or death, Roche noted.
Vyloy was approved as a first-line treatment for patients with CLDN18.2-positive gastric cancer by the European Commission last month.