Real-world use, dose intensity, and adherence to enfortumab vedotin in locally advanced or metastatic urothelial cancer

Urol Oncol. 2024 Jun;42(6):177.e1-177.e4. doi: 10.1016/j.urolonc.2024.03.001. Epub 2024 Mar 19.


Background: Enfortumab vedotin (EV) monotherapy is approved for the treatment of advanced urothelial cancer as later-line therapy (post-immunotherapy and -platinum-chemotherapy) and as earlier-line therapy (cisplatin-ineligible, at least 1 prior therapy). We examined real-world EV monotherapy use, dose intensity and adherence across 280 US cancer clinics.

Methods: This postmarketing study used data from a nationwide (United States) deidentified patient-level electronic health record-derived database. Included were patients with advanced urothelial cancer initiating EV on or after December 19, 2019 (date of accelerated approval). We summarized characteristics of EV users using descriptive statistics and computed metrics of EV use, EV dose intensity, and EV treatment adherence.

Results: We identified 416 advanced urothelial cancer patients initiating EV monotherapy. More than half of patients (55.3%) received EV as later-line therapy (3L+), and nearly half (44.7%) received EV as earlier line therapy (1 or 2L). Dosing frequency (mean [SD] 2.4 [0.5] treatments per 28 day cycle) and dose (1.1 [0.2] mg/kg) were lower than label indication guidelines (1.25 mg/kg, Day 1, 8, 15 of a 28 day cycle). Only 58.8% of patients received an average of >2 treatments per 28-day cycle.

Conclusions: Among patients with advanced urothelial cancer treated with EV monotherapy in contemporary practice, EV dosing frequency, and dosage was lower in clinical practice than recommended in the product labeling. Further research is required to understand clinical factors and outcomes associated with the differences observed.

Keywords: Enfortumab vedotin; Real-world data; Urothelial cancer.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal* / administration & dosage
  • Antibodies, Monoclonal* / therapeutic use
  • Carcinoma, Transitional Cell* / drug therapy
  • Carcinoma, Transitional Cell* / pathology
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Medication Adherence / statistics & numerical data
  • Middle Aged
  • Neoplasm Metastasis
  • Urinary Bladder Neoplasms / drug therapy
  • Urinary Bladder Neoplasms / pathology
  • Urologic Neoplasms / drug therapy
  • Urologic Neoplasms / pathology


  • enfortumab vedotin
  • Antibodies, Monoclonal