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CLAUDIN 18.2 IHC BIOMARKER
Assay Purpose:
Diagnostic : gastric or gastroesophageal junction (GEJ) adenocarcinoma
Drug: Zolbetuximab
Diagnostic test: CLDN18.2 Immunohistochemistry (IHC), VENTANA CLDN18 (43-14A) RxDx assay
Performed on block ***
Result: Positive OR Negative OR Inadequate OR EQUIVOCAL (See Comment)
Interpretation: % membranous tumoral with moderate/strong staining - Negative (< 75%), Positive (>= 75%)
Batch control: Adequate; on slide controls: Adequate
Disclaimer: Based on the CLDN18.2-positive status, this patient may be eligible for treatment with VYLOY™ (Zolbetuximab)—a CLDN18.2-directed cytolytic antibody—in combination with fluoropyrimidine- and platinum-containing chemotherapy. This therapeutic regimen is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Shitara, K., et al. (2023).
Zolbetuximab plus mFOLFOX6 in Claudin 18.2–Positive, HER2-Negative, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (SPOTLIGHT): A Randomized, Double-Blind, Phase 3 Trial. The Lancet, 401(10374), 1655–1668.https://doi.org/10.1016/S0140-6736(23)00498-7
Test ID: BMCLAUDIN18