Improve treatment options of Gastric/GEJ Adenocarcinoma by testing for CLDN18.2
Claudin18 is a NEW actionable target for patients with advanced or metastatic Gastric/GEJ Adenocarcinoma who may be eligible for biomarker-driven therapy. NeoGenomics is one of the leading laboratories that offers Claudin18 testing.
In 2024, an estimated 26,890 new cases of gastric cancer and 22,370 new cases of esophageal cancer will be diagnosed in the US.1,2 Most cases are diagnosed in advanced stage contributing to poor outcomes. The 5-year survival rate in advanced disease (stages III/IV) is 7%.
Because of this, there is an urgent need for first-line treatment options for patients with CLDN18.2+, locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.3
Claudin18.2 has emerged as a key biomarker in gastric cancer. By targeting this specific protein, new therapies can offer more personalized and effective treatment options. For oncologists and pathologists, understanding Claudin18.2's role can improve patient outcomes, providing hope for those battling this challenging disease. Explore how Claudin18.2 is shaping the future of oncology and transforming the standard of care.
Biomarker informed decision making reveals opportunities to advance care and provide insight on previously unknown patient populations. Claudin18.2 is a new companion biomarker making it a useful tool for targeted therapy.
Current established biomarker testing such as HER2, MSI, and PD-L1, is supported by clinical guidelines to aid in personalized treatment and inform clinical decisions.5
70% of gastric/GEJ cancers have Claudin18 at any expression level. 38% of patients have moderate to high expression levels of Claudin18.2 and may benefit from using a targeted biomarker assay to inform treatment decisions that may improve outcomes.5
Personalized patient care starts with precision oncology.
Belonging to the family of transmembrane proteins, Claudins reside throughout the body within the tight junctions formed between epithelial cells, regulating cellular structure and function5. Impacted cellular function can promote oncogenesis and thus cancer progression, making Claudins an attractive biomarker for targeted therapy.
CLDN18.2 is detected via IHC, as is standard with many other biomarkers. IHC scoring for CLDN18 in G/GEJ cancer is performed based on membrane staining intensity and percent of positive tumor cells.
CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining by IHC. CLDN18.2 expression has been seen in both diffuse-type gastric tumors and intestinal-type gastric tumors.
Resources
FAQs
Claudins are a family of transmembrane proteins. As a component of tight junctions, claudins are involved in the regulation of permeability, barrier function, and polarity of epithelial layers.6,7
Claudin18 FDA (VYLOY®) for Gastric/GEJ Adenocarcinoma IHC assay with a 48 hour TAT.
In recent studies, ~38% of cases demonstrated ≥75% of tumor cells with moderate-to-strong membranous CLDN18 staining.8,9
Yes, a new therapy has recently been launched to the market that targets CLDN18.2.
For CLDN18 evaluation, tissue submitted must have ≥50 viable tumor cells present. For a full list of specimen requirements, please see Test Menu
References:
- https://seer.cancer.gov/statfacts/html/stomach.html
- https://seer.cancer.gov/statfacts/html/esoph.html
- https://www.mdpi.com/2072-6694/16/3/679
- https://www.fgfr2b.com/
- https://www.gastriccancerbiomarkers.com/#cldn18-2-biomarker
- Tsukita S, Tanaka H, Tamura A. The claudins: from tight junctions to biological systems. Trends Biochem Sci 2019;44(2):141-52.
- Hu YJ, Wang YD, Tan FQ, Yang WX. Regulation of paracellular permeability: factors and mechanisms. Mol Biol Rep 2013;40:6123-42.
- Shitara K, Lordick F, Bang YJ, et al. Lancet 2023 Apr 14:S0140-6736(23)00620-7.
- Xu RH, Shitara K, Ajani JA, et al. #405736. Presented at: March American Society of Clinical Oncology Plenary Series; March 22, 2023.
Contact Us To Get Started!
Work with us – your premier oncology partner – to optimize cancer care for patients