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Synonyms: ASG-22CE | enfortumab vedotin-ejfv | Padcev®
enfortumab vedotin is an approved drug (FDA (2019), EMA (2022))
Compound class:
Antibody
Comment: Enfortumab vedotin is an anti-Nectin 4 monoclonal antibody-drug conjugate [3]. The toxic payload is monomethyl auristatin E (MMAE; PubChem CID 11542188). It exhibits potent efficacy in multiple preclinical cancer models [1].
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Summary of Clinical Use  |
| Enfortumab vedotin was advanced to clinical trials in cancer patients, in particular for bladder/urothelial cancers [2]. It was FDA approved in 2019 (under the FDA's accelerated approval process), for patients with locally advanced/metastatic urothelial cancer, for which immune checkpoint inhibitor therapies have been unsuccessful. It was the first anti-nectin 4 therapeutic to reach the clinic. Enfortumab vedotin with pembrolizumab, was approved by the FDA in April 2023, to treat locally advanced or metastatic urothelial carcinoma (when cisplatin-containing chemotherapy is not suitable). |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT03219333 | A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer | Phase 2 Interventional | Astellas Pharma Inc | ||
| NCT03474107 | A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) | Phase 3 Interventional | Astellas Pharma Inc | ||
