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