Evidence map›Paper›PMID 40460988›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2025

Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial.

T B Powles, M S Van der Heijden, Y Loriot, J Bedke, B P Valderrama, G Iyer, E Kikuchi, J Hoffman-Censits, C Vulsteke, A Drakaki and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Observational
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  11. Coordinated Expression of ADC TargetsCurrent issues in molecular biology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

T B PowlesDepartment of Genitourinary Oncology, Barts Cancer Centre NIHR Biomedical Research Centre, Queen Mary University of London, London, UK. Electronic address: thomas.powles1@nhs.net.
M S Van der HeijdenDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Y LoriotDepartment of Cancer Medicine, Institut Gustave Roussy, Université Paris-Saclay, Villejuif, France.
J BedkeDepartment of Urology & Transplantation Surgery, Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Stuttgart, Germany.
B P ValderramaMedical Oncology Department, Hospital Universitario Virgen del Rocio, Seville, Spain.
G IyerDepartment of Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.
E KikuchiDepartment of Urology, St. Marianna University School of Medicine, Kawasaki, Japan.
J Hoffman-CensitsDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Center, Baltimore, USA; Department of Urology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Center, Baltimore, USA.
C VulstekeDepartment of Integrated Cancer Center Ghent, AZ Maria Middelares and Center for Oncological Research (CORE), Antwerp University, Antwerp, Belgium.
A DrakakiDivision of Hematology Oncology, David Geffen School of Medicine, Department of University of California, Los Angeles Medical Center, Los Angeles, USA.
S RauschDepartment of Urology, Eberhard Karls University, Tübingen, Germany.
W ArafatDivision of Hematology and Oncology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, USA.
S H ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
U SwamiDivision of Medical Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, USA.
J-R LiDivision of Urology, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan.
I DuranMedical Oncology Department, Hospital Universitario Marques de Valdecilla, IDIVAL Santander, Spain.
S GorlaDepartment of Medical Oncology, Astellas Pharma, Inc., Northbrook, USA.
B Homet MorenoDepartment of Medical Oncology, Merck & Co., Inc., Rahway, USA.
X YuOncology Division, Pfizer Inc., Bothell, USA.
Y-T LuOncology Division, Pfizer Inc., Bothell, USA.
S GuptaDepartment of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAt the primary analysis of the EV-302 trial, enfortumab vedotin plus pembrolizumab (EV+P) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). PATIENTS AND

methodsWe present an updated analysis of efficacy and safety in the overall population, with a median follow-up of 2.5 years, providing an additional year of follow-up since the primary analysis.

resultsThe median PFS by blinded independent central review was 12.5 months [95% confidence interval (CI) 10.4-16.6 months] for the EV+P arm and 6.3 months (95% CI 6.2-6.5 months) for the chemotherapy arm [hazard ratio (HR) 0.48, 95% CI 0.41-0.57]. The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) for the chemotherapy arm (HR 0.51, 95% CI 0.43-0.61). Safety data with an additional year of follow-up were consistent with those of the primary analysis.

conclusionThe continued survival benefit with EV+P compared with chemotherapy in this updated analysis reinforces EV+P as the standard of care for the first-line treatment of patients with la/mUC.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellUrinary Bladder NeoplasmsUrologic NeoplasmsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedenfortumab vedotinpembrolizumabantibody-drug conjugateenfortumab vedotinEV-302overall survivalpembrolizumabprogression-free survival

Identifiers

PMID40460988

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.