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Genekor’s Pathology Laboratory now offers the Claudin 18.2 (CLDN 18.2) test, used to administer Zolbetuximab in combination with chemotherapy for patients with advanced or metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma.
On September 20th, the EMA approved Zolbetuximab for patients with HER2-negative/Claudin 18.2-positive advanced or metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma as a first-line treatment alongside chemotherapy, based on the results from the phase II GLOW and SPOTLIGHT studies.
In the U.S., Zolbetuximab recently received FDA approval (October 18, 2024), while new studies featuring various new drugs for Claudin 18.2-positive advanced or metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma were presented at this year’s ESMO (ESMO POSTERS 1,2,3).
Additionally, Claudin 18.2 serves as a prognostic biomarker for pancreatic cancer. At ESMO this year, phase II GLEAM study design was presented, exploring the use of Zolbetuximab in combination with chemotherapy for pancreatic cancer patients. In this study, 27.7% of patients exhibited positive Claudin 18.2 (≥ 75%).
The determination of Claudin 18.2 is performed immunohistochemically on biopsy material, surgical specimens, or paraffin-embedded tissue blocks for gastric/gastroesophageal junction adenocarcinomas. The automated Ventana BenchMark Ultra platform is utilized.
Based on recent studies, moderate (2+) to strong (3+) complete or incomplete membranous immunohistochemical expression of neoplastic cells in 75% or more of the sample is now proposed to be considered positive expression. An external positive control is used.
The experienced and specialized team at Genekor is here to provide doctors with the most reliable and accurate results, aiming to support their efforts in offering the best possible care to their patients.
Laboratory Address: E. Antistaseos 72 & Aiantos, 55133, Kalamaria, Thessaloniki
Phone: +30 2316003677