Enfortumab Vedotin as Third-Line Treatment Improves Overall Survival for Patients With Advanced Urothelial Carcinoma in the EV-301 Trial

By Hiten D. Patel, MD, MPH - Last Updated: March 26, 2021

The phase 3 EV-301 trial reported enfortumab vedotin prolonged overall survival (OS) among patients who had previously received chemotherapy and checkpoint inhibitors for advanced urothelial carcinoma. During the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium, Dr. Thomas Powles and colleagues presented data on 608 patients randomized to enfortumab vedotin versus investigator choice of chemotherapy (docetaxel, paclitaxel, or vinflunine) for patients who were previously treated with platinum-based chemotherapy and then progressed during or after PD-1/L1 inhibitor therapy.

Enfortumab vedotin is an antibody-drug conjugate directed against Nectin-4. Patients who progress after prior chemotherapy and checkpoint inhibitor therapy have poor outcomes, but enfortumab vedotin was found to extend median OS from 9.0 months to 12.9 months without a significant increase in the rate of grade ≥3 treatment-related adverse events (51.4% for enfortumab vedotin vs. 49.8% for chemotherapy). The authors conclude that given the “robust clinical benefit and a tolerable safety profile, enfortumab vedotin is a new standard of care for this aggressive disease.” The results of EV-301 come as enfortumab vedotin is also being studied in other populations of advanced urothelial carcinoma, such as in EV-201 with platinum-ineligible patients who progressed on PD-1/L1 inhibitor therapy and for use in combination with other agents.


J Clin Oncol 39, 2021 (suppl 6; abstr 393)

Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Feb 12 (Epub ahead of print. PMID: 33577729.)