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Enfortumab Vedotin-Related Skin Toxicities: Insights From Clinical and Histopathological Analysis

Yuki Kuma1, Makiko Kido-Nakahara1, Yoko Kuba-Fuyuno1

  • 1Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

The Journal of Dermatology
|October 16, 2025
PubMed

Insights

Enfortumab vedotin (EV) effectively treats advanced urothelial carcinoma but causes skin issues. This study suggests prior immune checkpoint inhibitor (ICI) therapy and higher EV doses may increase skin toxicity, possibly via direct damage or immune responses.

Area of Science:

  • Oncology
  • Dermatology
  • Pharmacology

Background:

  • Enfortumab vedotin (EV) is a vital treatment for advanced urothelial carcinoma.
  • Skin toxicities are a common and significant side effect of EV therapy.
  • The underlying mechanisms of EV-related skin toxicity (EVST) require further elucidation.

Purpose of the Study:

  • To investigate the association between prior immune checkpoint inhibitor (ICI) therapy and the development of EVST.
  • To explore the impact of higher EV doses on the incidence and severity of EVST.
  • To understand the histopathological basis of EVST.

Main Methods:

  • Retrospective analysis of patients treated with EV for advanced urothelial carcinoma.
  • Correlation of EVST development with prior ICI exposure and EV dosage.
  • Histopathological examination of skin biopsy specimens from patients experiencing EVST.

Main Results:

  • Prior ICI therapy was associated with an increased risk of developing EVST.
  • Higher cumulative EV doses correlated with a greater likelihood of EVST.
  • Histopathology revealed evidence of direct keratinocyte injury and immune-mediated inflammatory processes.

Conclusions:

  • Prior ICI use and higher EV doses are potential risk factors for EVST.
  • EVST likely involves both direct drug toxicity and immune-related mechanisms.
  • These findings may inform strategies for managing and preventing EVST in clinical practice.
Keywords:
Enfortumab vedotinimmune checkpoint inhibitorsskin toxicityurothelial carcinomaantibody‐drug conjugate

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