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Tier 3 — Observational / field trialPeer-reviewed

Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial

Evan Y. Yu, Daniel P. Petrylak, Peter H. O’Donnell, Jae‐Lyun Lee, Michiel S. van der Heijden, Yohann Loriot, Mark N. Stein, Andrea Necchi, Takahiro Kojima, Michael R. Harrison, Se Hoon Park, David I. Quinn, Elisabeth I. Heath, Jonathan E. Rosenberg, Joyce Steinberg, Shang-Ying Liang, Janet Trowbridge, Mary S. Campbell, Bradley A. McGregor, Arjun Vasant Balar

The Lancet Oncology · 2021

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Summary

EV-201 was a multicentre, single-arm phase 2 trial evaluating enfortumab vedotin in cisplatin-ineligible patients with advanced urothelial carcinoma who had experienced disease progression following PD-1 or PD-L1 inhibitor therapy. As suggested by the trial design and publication in The Lancet Oncology (2021), the study likely reports efficacy outcomes and safety data for this patient population, though without access to the full text, specific effect sizes and conclusions cannot be stated with certainty.

UK applicability

If enfortumab vedotin demonstrates clinical benefit in this trial, findings would be relevant to UK oncology practice, subject to National Institute for Health and Care Excellence appraisal and NHS commissioning decisions. However, applicability depends on trial outcomes, trial conduct sites, and alignment with UK-standard immunotherapy sequencing.

Key measures

Objective response rate, duration of response, adverse event incidence and grading (as typical for oncology phase 2 trials)

Outcomes reported

The study assessed clinical efficacy and safety of enfortumab vedotin (a Nectin-4-directed ADC) in cisplatin-ineligible patients with advanced urothelial carcinoma who had progressed on or after PD-1/PD-L1 inhibitor therapy. Efficacy endpoints likely included objective response rate, duration of response, and progression-free or overall survival; safety profiling included adverse event incidence and severity.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase 2 trial, multicentre, single-arm
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s1470-2045(21)00094-2
Catalogue ID
BFmommpjky-ilfmqw

Topic tags

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