Dr. Garyfalia Karponi
Background
Bladder cancer is the ninth most common cancer worldwide, with more than 614,000 newly diagnosed individuals annually across the globe [1].
Nectin-4 is a cell adhesion molecule expressed in both normal and cancerous tissues and is involved in multiple cellular processes known to be associated with oncogenesis, including cell adhesion, migration, proliferation, differentiation and survival [2].
High expression of nectin-4 in specific solid tumors, including pancreatic, lung, breast, ovarian and esophageal cancers, is associated with poor prognosis [3–9].
The increased expression levels of nectin-4 in urothelial carcinoma and other tumors, compared with its low to moderate expression in normal tissues, make it a strong therapeutic target for drug development [2, 3].
Enfortumab vedotin is a monoclonal antibody that, by targeting nectin-4 on cancer cells, causes microtubule inhibition and cell death, significantly changing the therapeutic management of urothelial cancer [3, 10].
It is mainly used in patients with metastatic or unresectable urothelial cancer, as well as in patients previously treated with platinum-based therapy or immunotherapy (PD-1/PD-L1). In more recent guidelines/studies, enfortumab now also has a role earlier in the treatment sequence, especially in combination with immunotherapy [11, 12, 13].
What we offer
Immunohistochemical testing for Nectin-4 overexpression, either as a standalone test or as part of our molecular testing panel for urothelial cancer, UrinArray Broad.
It should be noted that Nectin-4 testing within our UrinArray Broad panel will not involve any additional financial burden for the patient.
References
World Bladder Cancer Patient Coalition. GLOBOCAN 2022: Bladder cancer 9th most common worldwide. Accessed June 23, 2025.
Boylan KLM. Oncotarget. 2017:9717–38.
Challita-Eid PM. Cancer Res. 2016:3003–13.
Zhang Y. Cancer Lett. 2016:179–89.
Deng H. Cancer Cell Int. 2019;19(106):1–13.
DeRycke MS. Am J Clin Pathol. 2010;134(5):835–45.
Nishiwada S. J Exp Clin Cancer Res. 2015;34(30):1–9.
Takano A. Cancer Res. 2009;69(16):6694–703.
Zeindler J. Front Med. 2019;6(200):1–7.
PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc.
FDA. (2019, December 18). FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer. U.S. Food and Drug Administration. Accessed December 9, 2025.
FDA. (2021, July 9). FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer. U.S. Food and Drug Administration. Accessed December 9, 2025.
European Medicines Agency. (2022, April 13). Padcev (enfortumab vedotin): EPAR – product information. EMA. Accessed December 9, 2025.
Contact us for more information.
Garyfalia Karponi, MSc, PhD
Molecular Biologist–Geneticist
Certified Laboratory Geneticist
Chief Scientific Officer, Department of Molecular Diagnostics