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VENTANA® CLDN18 (43-14A) RxDx Assay

Predictive IHC Assay, FDA
IVD For in vitro diagnostic use.
VENTANA CLDN18 (43-14A) RxDx Assay

The first FDA-approved immunohistochemistry (IHC) companion diagnostic for determining Claudin 18 (CLDN18) protein expression in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who may be eligible for CLDN18.2-targeted treatment with Astellas’ VYLOY® (zolbetuximab-clzb).1

gastrointestinal icon

Gastric and gastroesophageal cancer has a large unmet need with opportunities for diagnostic and therapeutic improvement 

In the US, G/GEJ cancer is considered rare.2 

  • It is often diagnosed late as signs and symptoms are common to other conditions.2
  • 62% of G/GEJ cases are advanced at initial diagnosis and have a 5-year overall survival rate of only 6%.3,4
lab technicians with microsope

We developed the first and only FDA-approved assay to detect CLDN18

  • Claudins are present throughout the body, but isoform 18.2 is the dominant isoform in gastric and esophageal tissues.5,6
  • Approximately 38% of patients with locally advanced unresectable or mG/GEJ cancer are CLDN18.2 positive (at the clinical cutoff of ≥75% viable tumor cells (% TC) demonstrating moderate to strong membrane CLDN18 staining above background)7,8,*, and ~70% of advanced G/GEJ cancers express CLDN18.2 at any detectable amount.9,†

* Data from 2 global, randomized phase 3 studies: the first study included 2,403 assessable patients, of which 922 were CLDN18.2 positive; and a second study which included 2,104 assessable patients, of which 808 were CLDN18.2 positive.7,8

† Data from a retrospective analysis of 350 Caucasian patients with advanced G/GEJ cancer.9

cldn18 stain
  • CLDN18.2 is a biomarker expressed in a variety of cancers. Guidelines for G/GEJ cancer support using novel biomarkers to help map the path forward for patients.9,10     
  • The VENTANA CLDN18 (43-14A) RxDx Assay informs clinicians about the likelihood of patient benefit from CLDN18.2-targeted therapy.1  
  • The FDA-approved VENTANA CLDN18 (43-14A) RxDx Assay measures expression of both variants of the CLDN18 protein; however, CLDN18.2 is the dominant variant expressed in gastric cancers, making it the only candidate for identifying a previously undefined subset of patients.6   
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FDA-approved VENTANA CLDN18 (43-14A) RxDx Assay identified patients for a new therapy that demonstrated a clinically meaningful PFS benefit in CLDN18-positive patients as supported by data from 2 clinical trials1,12,13

  • FDA approval for the VENTANA CLDN18 (43-14A) RxDx Assay is based on data from Astellas’ SPOTLIGHT and GLOW clinical studies.12,13 For more information on two phase 3 trials visit VYLOYhcp.com.
  • The VENTANA CLDN18 (43-14A) RxDx Assay was used as the enrollment assay to identify patients whose tumors were positive for CLDN18.2 defined as ≥75% tumor cells (TC) demonstrating moderate to strong membrane CLDN18.2 staining.12,13
Download the Interpretation Guide

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Patients who received zolbetuximab experienced a 
 


reduction in disease progression or death12,13

Kaplan-Meier curve for PFS in SPOTLIGHT7

Progression-free survival (PFS)* of 10.61 months† vs 8.67 months in the placebo arm of the trial.

Kaplan-Meier curve for PFS in SPOTLIGHT
Kaplan-Meier curve for PFS in SPOTLIGHT
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Kaplan-Meier curve for PFS in GLOW14

PFS* of 8.21 months† vs 6.80 months in the placebo arm of the trial.

Kaplan-Meier curve for PFS in GLOW
Kaplan-Meier curve for PFS in GLOW

Want to learn more about the therapy associated with VENTANA CLDN18 (43-14A) RxDx Assay? 

Learn more
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Detecting CLDN18.2 is key to determining eligibility for VYLOY® (zolbetuximab-clzb)

  • CLDN18.2 expression was assessed by IHC using the investigational VENTANA CLDN18 (43-14A) RxDx Assay in the SPOTLIGHT and GLOW clinical trials.8
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The VENTANA CLDN18 (43-14A) RxDx Assay is the latest addition to Roche’s market-leading portfolio of IHC/ISH companion diagnostics designed to provide critical insights that enable more informed clinical decisions and improve patient outcomes.

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Submit your details in order to be contacted by a Roche representative in your region with more details about VENTANA CLDN18 (43-14A) RxDx Assay and its availability in your region.

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Related products

IHC and ISH reagents and ancillaries

To view associated reagents, ancillaries, and bulks, please visit the Roche Tissue Diagnostics reagent catalog.

Reagent catalog

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References

  1. VENTANA CLDN18 (43-14A) RxDx Assay. US Package Insert. Roche Diagnostics; 2023. 
  2. National Cancer Institute. Gastric cancer treatment. Accessed September 26, 2023. https://www.cancer.gov/types/stomach/patient/stomach-treatment-pdq 
  3. American Cancer Society. Cancer facts & figures 2022. Accessed September 9, 2023. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf 
  4. NCI SEER. Cancer stat facts: stomach cancer. Accessed September 26, 2023. https://seer.cancer.gov/statfacts/html/stomach.html 
  5. Sahin U, Koslowski M, Dhaene K, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008;14(23):7624-7634. 
  6. Saito T, Matsuda T, Moran D. P-114 Claudin 18 isoform expression in gastric adenocarcinoma and pancreatic adenocarcinoma. Annals of Oncology. July 2021. Accessed September 26. 2023. doi: https://doi.org/10.1016/j.annonc.2021.05.169 
  7. Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial [published correction appears in Lancet. 2023;402(10398):290]. Lancet. 2023;401(10389):1655-1668. 
  8. Xu RH, Shitara K, Ajani JA, et al. Abstract #405736. Presented at: American Society of Clinical Oncology Plenary Series; March 22, 2023. 
  9. Pellino A, Brignola S, Riello E, et al. Association of CLDN18 protein expression with clinicopathological features and prognosis in advanced gastric and gastroesophageal junction adenocarcinomas. J Pers Med. 2021;11(11):1095. 
  10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2022. © National Comprehensive Cancer Network, Inc. 2022.  All rights reserved.  Accessed January 12, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 
  11. Wang FH, Zhang XT, Li YF, et al. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021. Cancer Commun. 2021;41(8):747-95. 
  12. Astellas to present positive findings from phase 3 SPOTLIGHT trial of zolbetuximab during 2023 ASCO GI Cancers Symposium. News release. Astellas; January 20, 2023. Accessed September 26, 2023. https://www.astellas.com/en/news/26946 
  13. Astellas announces positive findings from phase 3 GLOW trial of zolbetuximab during March ASCO Plenary Series. News release. Astellas; March 22, 2023. Accessed September 26, 2023. https://www.astellas.com/en/news/27481 
  14. Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29:2133–2141.

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