Evidence map›Paper›PMID 33577729›Full record

Trial reportThe New England journal of medicine2021

Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma.

Thomas Powles, Jonathan E Rosenberg, Guru P Sonpavde, Yohann Loriot, Ignacio Durán, Jae-Lyun Lee, Nobuaki Matsubara, Christof Vulsteke, Daniel Castellano, Chunzhang Wu and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 673 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
673citing papers in PubMed, 5 pooled it
157.2field-weighted citation impact, top 1% of its field
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.

NCT03474107 phase3completednot on this map

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2025Enrolled608ConditionsUreteral Cancer, Urothelial Cancer, Bladder CancerArmsEnfortumab Vedotin, Docetaxel, Vinflunine, Paclitaxel
NCT05700344 completednot on this mapstarted 2022, after this paper: background citation

Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

TypeobservationalSponsorSpanish Oncology Genito-Urinary GroupRan2022 to 2023Enrolled125ConditionsMetastatic Urothelial CarcinomaArmsAvelumab
3 · Its place in the literature

Who cites it

673 citing papers in PubMed, 5 syntheses or guidelines pooled it, 1,097 citations in OpenAlex.

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  5. SEOM-SOGUG clinical guideline for urothelial cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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  7. Benralizumab for Eosinophil-Related Cutaneous Adverse Events of Anticancer Therapy: A Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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613 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 7 countries.

Thomas PowlesFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Jonathan E RosenbergFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Guru P SonpavdeFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Yohann LoriotFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Ignacio DuránFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Jae-Lyun LeeFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Nobuaki MatsubaraFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Christof VulstekeFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Daniel CastellanoFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Chunzhang WuFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Mary CampbellFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Maria MatsangouFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Daniel P PetrylakFrom Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) - both in Spain; Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); National Cancer Center Hospital East, Chiba, Japan (N.M.); the Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium (C.V.); Astellas Pharma, Northbrook, IL (C.W., M.M.); Seagen, Bothell, WA (M.C.); and Smilow Cancer Center, Yale School of Medicine, New Haven, CT (D.P.P.).
Astellas Pharma (United States) · USHarvard University · USHospital Universitario 12 De Octubre · ESInstitut Gustave Roussy · FRInstituto de Investigación Marqués de Valdecilla · ESMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPQueen Mary University of London · GBSeagen (United States) · USSmilow Cancer Hospital · USUlsan College · KRUniversity of Antwerp · BE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SPORE in Bladder CancerP50CA221745 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI BAJORIN, DEAN F. · 2018 to 2024
$11.8M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA221745
6 · The paper itself

Abstract

backgroundPatients with advanced urothelial carcinoma have poor overall survival after platinum-containing chemotherapy and programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor treatment.

methodsWe conducted a global, open-label, phase 3 trial of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-containing chemotherapy and had had disease progression during or after treatment with a PD-1 or PD-L1 inhibitor. Patients were randomly assigned in a 1:1 ratio to receive enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight on days 1, 8, and 15 of a 28-day cycle) or investigator-chosen chemotherapy (standard docetaxel, paclitaxel, or vinflunine), administered on day 1 of a 21-day cycle. The primary end point was overall survival.

resultsA total of 608 patients underwent randomization; 301 were assigned to receive enfortumab vedotin and 307 to receive chemotherapy. As of July 15, 2020, a total of 301 deaths had occurred (134 in the enfortumab vedotin group and 167 in the chemotherapy group). At the prespecified interim analysis, the median follow-up was 11.1 months. Overall survival was longer in the enfortumab vedotin group than in the chemotherapy group (median overall survival, 12.88 vs. 8.97 months; hazard ratio for death, 0.70; 95% confidence interval [CI], 0.56 to 0.89; P = 0.001). Progression-free survival was also longer in the enfortumab vedotin group than in the chemotherapy group (median progression-free survival, 5.55 vs. 3.71 months; hazard ratio for progression or death, 0.62; 95% CI, 0.51 to 0.75; P<0.001). The incidence of treatment-related adverse events was similar in the two groups (93.9% in the enfortumab vedotin group and 91.8% in the chemotherapy group); the incidence of events of grade 3 or higher was also similar in the two groups (51.4% and 49.8%, respectively).

conclusionsEnfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based treatment and a PD-1 or PD-L1 inhibitor. (Funded by Astellas Pharma US and Seagen; EV-301 ClinicalTrials.gov number, NCT03474107.).

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCell Adhesion MoleculesDrug Resistance, NeoplasmFemaleHumansIntention to Treat AnalysisMaleMiddle AgedNectinsProgrammed Cell Death 1 Ligand 2 ProteinProgrammed Cell Death 1 ReceptorAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalCell Adhesion Moleculesenfortumab vedotinNECTIN4 protein, humanNectinsProgrammed Cell Death 1 Ligand 2 ProteinProgrammed Cell Death 1 Receptor

Identifiers

PMID33577729
PMCPMC8450892
OpenAlexW3127912627

What OpenQuestion holds

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Registered trials

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 OpenQuestion graph.