Clinical Outcomes of Metastatic Urothelial Carcinoma Patients Discontinuing Enfortumab Vedotin Due to Toxicity and/or Clinical Response.

Authors

Joy Li, Jordan Fredette, Nagendra Dhanikonda, Miraan Jhaveri, Aangi Shah, Lucas Viti-Guzman, Jasmeet Kaur, Andre T Kydd, Fern Anari, Daniel M Geynisman, Elizabeth R Plimack, Matthew R Zibelman, Pooja Ghatalia

Published in

Clinical genitourinary cancer. Pages 102631. Jul 29, 2026. Epub Jul 29, 2026.

Abstract

Enfortumab vedotin (EV), alone or in combination with pembrolizumab (EV/P) are established treatment for metastatic urothelial carcinoma (mUC). Patients who discontinue EV after achieving a complete or partial response (CR/PR), or due to toxicity, may maintain durable disease control.
We retrospectively analyzed 147 patients with mUC treated with ≥2 cycles of EV or EV/P at our institution. The primary endpoint was treatment-free interval (TFI) among patients who discontinued EV for ≥8 consecutive weeks due to CR/PR and/or toxicity. Patients receiving EV/P may have continued pembrolizumab after discontinuing EV. TFI was evaluated through competing risks analysis with treatment re-initiation and death modeled as competing risks by both cumulative incidence functions and Fine-Gray regression.
A total of 73 patients discontinued EV due to toxicity and/or CR/PR. At 1 year following EV discontinuation, 41.9% of EV-treated and 68.9% of EV/P-treated patients remained alive and treatment-free. Duration of EV was not associated with TFI (EV: HR 1.02, P = .78; EV/P: HR 0.88, P = .18). Achieving CR was associated with longer TFI compared with PR (HR 2.94, P = .03). Among the 23 patients who restarted EV at progression, 21.7% achieved PR, 30.4% stable disease, and 47.8% experienced progressive disease.
Among selected patients with mUC who discontinued EV due to toxicity or clinical response, prolonged intervals without subsequent systemic therapy were observed. EV rechallenge at progression demonstrated clinical activity in a subset of patients. Prospective studies are warranted to optimize treatment duration and explore the role of EV rechallenge.

PMID:
42618453
Bibliographic data and abstract were imported from PubMed on 20 Aug 2026.

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