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Thomas Flaig, MD


ASCO 2022: 2-Year Follow-up on Enfortumab Vedotin for Urothelial Cancer

By: Lauren Harrison, MD, MS
Posted: Friday, June 17, 2022

Enfortumab vedotin-ejfv, an antibody-drug conjugate directed against Nectin-4, has continued to show a significant survival advantage over standard chemotherapy among patients with previously treated metastatic urothelial carcinoma. Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, New York, presented 24-month findings for enfortumab vedotin versus chemotherapy on behalf of his colleagues at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4516).

“With robust clinical benefit and a tolerable safety profile, [enfortumab vedotin] maintains its place as a standard of care for this aggressive disease,” concluded the authors.

This phase III randomized trial enrolled 609 patients with locally advanced or metastatic urothelial carcinoma. All patients received prior platinum-containing chemotherapy and had experienced disease progression while undergoing PD-1/PD-L1 inhibitor therapy. Patients were randomly assigned 1:1 to receive either enfortumab vedotin or investigator-chosen chemotherapy. Enfortumab vedotin was given at a dose of 1.25 mg/kg on days 1, 8, and 15 of a 28-day cycle.

After almost 2 years of follow-up, the median overall survival was extended by 4.0 months with enfortumab vedotin compared with standard chemotherapy (median overall survival 12.9 months vs. 8.9 months, respectively, P < .001). This survival benefit was seen in most of the prespecified subgroups as well. Progression-free survival was similarly improved with enfortumab vedotin (5.6 months vs. 3.7 months with chemotherapy, P < .0001).

There were no new safety signals identified in this longer-term follow-up. The rates of treatment-related adverse events were similar between the two groups, with 93.9% of patients given enfortumab vedotin and 91.8% of those given chemotherapy experiencing adverse events. Serious adverse events were noted in 22.6% of the experimental group and 23.4% of the standard-treatment group. Rates of grade ≥ 3 adverse events were seen in about 50% of patients in both groups.

Disclosure: For a full list of authors’ disclosures, visit

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