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GU Symposium 2021: Enfortumab Vedotin Versus Chemotherapy for Advanced Urothelial Carcinoma

By: Sarah Campen, PharmD
Posted: Wednesday, February 17, 2021

Enfortumab vedotin appears to significantly improve survival in previously treated patients with locally advanced or metastatic urothelial carcinoma compared with standard chemotherapy, according to the primary results of the EV-301 trial, which were presented at the virtual edition of the 2021 Genitourinary (GU) Cancers Symposium (Abstract 393). Enfortumab vedotin is a first-in-class antibody-drug conjugate directed against Nectin-4, a cell-adhesion molecule highly expressed in urothelial carcinoma. “With robust clinical benefit and a tolerable safety profile, enfortumab vedotin is a new standard of care for this aggressive disease,” stated Thomas Powles, MD, PhD, FCRP, of Barts Cancer Centre, Queen Mary University of London, United Kingdom, and colleagues.

The open-label phase III study included 608 patients with locally advanced or metastatic urothelial carcinoma who received prior platinum-containing chemotherapy and had disease progression during or after PD-1/PD-L1 inhibitor treatment. Patients were randomly assigned to receive enfortumab vedotin at 1.25 mg/kg on days 1, 8, and 15 of each 28-day cycle (n = 301) or investigator choice of standard docetaxel, paclitaxel, or vinflunine chemotherapy (n = 307).

After an 11.1-month follow-up, median overall survival was significantly longer in the enfortumab vedotin arm compared with chemotherapy (12.9 vs. 9.0 months); progression-free survival was also improved with enfortumab vedotin (5.6 vs. 3.7 months, respectively). Both objective response and disease control rates were significantly higher with enfortumab vedotin as well.

As of July 15, 2020, the enfortumab vedotin arm had 134 deaths, and the chemotherapy arm had 167 deaths. As for safety, the rates of treatment-related adverse events were comparable between the enfortumab vedotin and chemotherapy groups (93.9% vs. 91.8%), including serious treatment-related adverse events (22.6% vs. 23.4%).

Disclosure: For full disclosures of the study authors, visit

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