Enfortumab Vedotin Plus Pembrolizumab Improves Survival Outcomes for Urothelial Cancer Patients

Strategic Insights -

In a recent study published in the Lancet Oncology, researchers at the Cleveland Clinic Foundation found that the combination of enfortumab vedotin plus pembrolizumab significantly improved survival outcomes for patients with previously untreated locally advanced or metastatic urothelial cancer. The study, which enrolled 886 patients, found that the treatment combination not only improved progression-free survival and overall survival but also demonstrated clinically meaningful improvements in worst pain and quality of life for patients with moderate to severe baseline pain.

Key Takeaways:

  • The combination of enfortumab vedotin plus pembrolizumab improved progression-free survival and overall survival compared to platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer.
  • The treatment combination demonstrated clinically meaningful improvements in worst pain and quality of life for patients with moderate to severe baseline pain.
  • The study found that enfortumab vedotin plus pembrolizumab significantly improved survival outcomes without detriment to global health status, pain, or functioning.
  • The trial involved 731 patients who completed at least one patient-reported outcome questionnaire at baseline, with 376 patients receiving enfortumab vedotin plus pembrolizumab and 355 receiving platinum-based chemotherapy.
  • The study was conducted at 185 clinical sites in 25 countries, with a median duration of follow-up for survival of 17.2 months.

Statistics:

  • 731 patients completed at least one patient-reported outcome questionnaire at baseline, with 376 patients receiving enfortumab vedotin plus pembrolizumab and 355 receiving platinum-based chemotherapy.
  • 570 (78%) of 731 patients were male, 161 (22%) were female, and 479 (66%) patients were White.
  • The least squares mean change in EORTC QLQ-C30 Global Health Status (GHS)/QOL from baseline up to week 26 favored enfortumab vedotin plus pembrolizumab, with a least squares mean difference of 2.54.
  • In patients with moderate to severe baseline pain receiving enfortumab vedotin plus pembrolizumab, there were clinically meaningful improvements from baseline up to week 26 in worst pain, with a least squares mean change of -0.53.

Sources:

  • Lancet Oncology, 2025;26(6):795-805
  • Cleveland Clinic Foundation, Taussig Cancer Institute, Dept. of Hematology and Medical Oncology
  • Elsevier Science Inc, Ste 800, 230 Park Ave, New York, NY 10169, USA
  • NewsRx. Findings on Urothelial Cancer Discussed by Investigators at Cleveland Clinic Foundation [Enfortumab Vedotin Plus Pembrolizumab Versus Chemotherapy In Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (Ev-302): ...]. Immunotherapy Weekly. July 9, 2025; p 1997.