Evidence map›Paper›PMID 31356140›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy.

Jonathan E Rosenberg, Peter H O'Donnell, Arjun V Balar, Bradley A McGregor, Elisabeth I Heath, Evan Y Yu, Matthew D Galsky, Noah M Hahn, Elaina M Gartner, Juan M Pinelli and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 365 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
365citing papers in PubMed, 11 pooled it
70.9field-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.

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

365 citing papers in PubMed, 11 syntheses or guidelines pooled it, 609 citations in OpenAlex.

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  13. Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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305 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 11 institutions in 1 country.

Jonathan E RosenbergMemorial Sloan Kettering Cancer Center, New York, NY.
Peter H O'DonnellUniversity of Chicago, Chicago, IL.
Arjun V BalarNew York University Langone Health, New York, NY.
Bradley A McGregorDana-Farber Cancer Institute, Boston, MA.
Elisabeth I HeathWayne State University, Detroit, MI.
Evan Y YuFred Hutchinson Cancer Research Center, Seattle, WA.
Matthew D GalskyIcahn School of Medicine at Mount Sinai, New York, NY.
Noah M HahnJohns Hopkins University School of Medicine, Baltimore, MD.
Elaina M GartnerSeattle Genetics, Bothell, WA.
Juan M PinelliSeattle Genetics, Bothell, WA.
Shang-Ying LiangSeattle Genetics, Bothell, WA.
Amal Melhem-BertrandtAstellas Pharma, Northbrook, IL.
Daniel P PetrylakYale Cancer Center, New Haven, CT.
Seagen (United States) · USAstellas Pharma (United States) · USDana-Farber Cancer Institute · USIcahn School of Medicine at Mount Sinai · USJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USNYU Langone Health · USUniversity of Chicago · USUniversity of Washington · USWayne State University · USYale Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeLocally advanced or metastatic urothelial carcinoma is an incurable disease with limited treatment options, especially for patients who were previously treated with platinum and anti-programmed death 1 or anti-programmed death ligand 1 (PD-1/L1) therapy. Enfortumab vedotin is an antibody-drug conjugate that targets Nectin-4, which is highly expressed in urothelial carcinoma.

methodsEV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg/kg (intravenously on days 1, 8, and 15 of every 28-day cycle) in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum chemotherapy and anti-PD-1/L1 therapy. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review. Key secondary end points were duration of response, progression-free survival, overall survival, safety, and tolerability.

resultsEnfortumab vedotin was administered to 125 patients with metastatic urothelial carcinoma. Median follow-up was 10.2 months (range, 0.5 to 16.5 months). Confirmed objective response rate was 44% (95% CI, 35.1% to 53.2%), including 12% complete responses. Similar responses were observed in prespecified subgroups, such as those patients with liver metastases and those with no response to prior anti-PD-1/L1 therapy. Median duration of response was 7.6 months (range, 0.95 to 11.30+ months). The most common treatment-related adverse events were fatigue (50%), any peripheral neuropathy (50%), alopecia (49%), any rash (48%), decreased appetite (44%), and dysgeusia (40%). No single treatment-related adverse events grade 3 or greater occurred in 10% or more of patients.

conclusionEnfortumab vedotin demonstrated a clinically meaningful response rate with a manageable and tolerable safety profile in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum and anti-PD-1/L1 therapies.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalB7-H1 AntigenCohort StudiesFemaleHumansMaleMiddle AgedOrganoplatinum CompoundsProgrammed Cell Death 1 ReceptorUrologic NeoplasmsAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanenfortumab vedotinOrganoplatinum CompoundsPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID31356140
PMCPMC6784850
OpenAlexW2966500633

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.