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  1. Home
  3. Research Domains
  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
  9. Predictive And Prognostic Markers
  11. Enfortumab Vedotin In Previously Treated Advanced Urothelial Carcinoma.
  1. Home
  3. Research Domains
  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
  9. Predictive And Prognostic Markers
  11. Enfortumab Vedotin In Previously Treated Advanced Urothelial Carcinoma.

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Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma.

Thomas Powles1, Jonathan E Rosenberg1, Guru P Sonpavde1

  • 1From Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).

The New England Journal of Medicine
|February 12, 2021

View abstract on PubMed

Summary
This summary is machine-generated.

Enfortumab vedotin significantly improved overall survival in patients with advanced urothelial carcinoma previously treated with chemotherapy and immunotherapy. This finding offers a new treatment option for patients with poor prognosis.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Urothelial Carcinoma Treatment

Background:

  • Advanced urothelial carcinoma patients have limited survival after chemotherapy and PD-1/PD-L1 inhibitor treatment.
  • There is a need for more effective therapies in this patient population.

Purpose of the Study:

  • To evaluate the efficacy of enfortumab vedotin compared to chemotherapy in patients with advanced urothelial carcinoma.
  • To assess overall survival and progression-free survival in patients who progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitors.

Main Methods:

  • A global, open-label, phase 3 trial (EV-301) randomized 608 patients with advanced urothelial carcinoma.
  • Patients received either enfortumab vedotin or investigator-chosen chemotherapy (docetaxel, paclitaxel, or vinflunine).
  • The primary endpoint was overall survival.

    • Main Results:

    • Enfortumab vedotin demonstrated significantly longer median overall survival (12.88 vs. 8.97 months) compared to chemotherapy.
    • Progression-free survival was also significantly improved with enfortumab vedotin (5.55 vs. 3.71 months).
    • Treatment-related adverse events were similar between the two groups, with comparable rates of grade 3 or higher events.

    Conclusions:

    • Enfortumab vedotin significantly prolongs survival in patients with locally advanced or metastatic urothelial carcinoma who have progressed on prior platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
    • Enfortumab vedotin represents a new standard of care for this refractory patient population.