Evidence map›Paper›PMID 42155320›Full record

Trial reportESMO open2026

EV-103 dose escalation/cohort A: 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma.

J E Rosenberg, P H O'Donnell, D P Petrylak, T W Flaig, C J Hoimes, S Gupta, N Mar, T W Friedlander, S T Tagawa, M A Bilen and 10 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT03288545 phase1 / phase2terminatednot on this map

A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2017 to 2026Enrolled348ConditionsCarcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis NeoplasmsArmsenfortumab vedotin (EV), pembrolizumab, cisplatin, carboplatin, gemcitabine
NCT04223856 phase3active not recruitingnot on this map

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2020 to 2028Enrolled886ConditionsUrothelial CancerArmsEnfortumab vedotin, Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

J E RosenbergMemorial Sloan Kettering Cancer Center, New York, USA. Electronic address: rosenbj1@mskcc.org.
P H O'DonnellUniversity of Chicago, Chicago, USA.
D P PetrylakYale Cancer Center, New Haven, USA.
T W FlaigDivision of Medical Oncology, CU School of Medicine, Aurora, USA.
C J HoimesDuke Cancer Institute, Durham, USA.
S GuptaCleveland Clinic Taussig Cancer Institute, Cleveland, USA.
N MarUniversity of California Irvine, Irvine, USA.
T W FriedlanderUniversity of California San Francisco Medical Center, San Francisco, USA.
S T TagawaWeill Cornell Medical Center, New York, USA.
M A BilenWinship Cancer Institute of Emory University, Atlanta, USA.
J R BrownUniversity Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, USA.
R R McKayUniversity of California San Diego, San Diego, USA.
J R MerchanUniversity of Miami, Miami, USA.
S SrinivasStanford University Medical Center, Stanford, USA.
S GorlaAstellas Pharma, Inc., Northbrook, USA.
B H MorenoMerck & Co., Inc., Rahway, USA.
G DavisPfizer Inc., Bothell, USA.
H S WirtzPfizer Inc., Bothell, USA.
Y ZhuPfizer Inc., Bothell, USA.
M I MilowskyUniversity of North Carolina, Chapel Hill, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundDose escalation/cohort A of the phase Ib/II EV-103/KEYNOTE-869 study (NCT03288545) assessed safety and efficacy of enfortumab vedotin (EV) plus pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC). Here we report updated results after 5 years of follow-up.

methodsPatients received EV 1.25 mg/kg intravenously on days 1 and 8, and pembrolizumab 200 mg on day 1 of every 3-week cycle. The primary endpoint was safety. Select secondary endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

resultsForty-five patients were enrolled. Baseline characteristics were representative of a cisplatin-ineligible population; 84.4% had visceral disease and 55.6% had reduced renal function (creatine clearance <60 ml/min). The median follow-up time was 62.1 months [95% confidence interval (CI) 59.4-63.1]. There were no new safety signals, and safety was consistent with EV+P in other la/mUC studies. Confirmed ORR was 73.3%, median DOR was 22.1 months [95% CI 8.4-not estimable (NE)], median PFS was 12.7 months (95% CI 6.1-NE), and median OS was 26.1 months (95% CI 15.5-NE). The estimated 5-year survival rate was 41.5% (95% CI 26.5-56.0).

conclusionAlong with results from EV-302/KEYNOTE-A39 (NCT04223856), the 5-year results further support the sustained benefit from EV+P and establish the combination as the standard of care for previously untreated la/mUC.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellUrinary Bladder NeoplasmsUrologic NeoplasmsAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedenfortumab vedotinpembrolizumabenfortumab vedotinEV-103first linepembrolizumaburothelial cancer

Identifiers

PMID42155320
PMCPMC13213747

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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.