The Absolute Effect / Oncology Evidence / Evidence Index
EV-301
In advanced urothelial carcinoma after platinum chemotherapy and PD-1/PD-L1 inhibitor, does enfortumab vedotin improve overall survival over chemotherapy?
Registry: NCT03478592 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III open-label randomized; n=608.Primary-source evidence summaryStudy design, population and eligibility
Phase III open-label randomized; n=608.
Locally advanced/metastatic UC after platinum chemotherapy and PD-1/PD-L1 inhibitor.
Treatment and comparator
Intervention: Enfortumab vedotin days 1,8,15 q28d.
Comparator: Docetaxel, paclitaxel or vinflunine.
Endpoints
OS primary; PFS/ORR secondary.
Key efficacy and clinical outcomes
Median OS 12.88 vs 8.97 mo (HR .70); 12-mo OS 51.5% vs 39.2%.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. Advanced urothelial carcinoma after platinum and PD-1/PD-L1 inhibitor
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Rash, peripheral neuropathy, hyperglycaemia, ocular toxicity; rare severe skin reactions/pneumonitis.
Absolute effect and NNT/NNH
Distinct from EV-302 first-line enfortumab-pembrolizumab and perioperative EV-303/304.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Distinct from EV-302 first-line enfortumab-pembrolizumab and perioperative EV-303/304.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.