enfortumab vedotin

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Ligands
enfortumab vedotin

GtoPdb Ligand ID: 10738

Synonyms: ASG-22CE | enfortumab vedotin-ejfv | Padcev®

enfortumab vedotin is an approved drug (FDA (2019), EMA (2022))

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).

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