Evidence map›Paper›PMID 42142358›Full record

Trial reportFuture oncology (London, England)2026

TROPION-Urothelial03: a phase II/III study of datopotamab deruxtecan (Dato-DXd) for locally advanced or metastatic urothelial carcinoma.

Matthew D Galsky, Alexandra Drakaki, Arnab Basu, Bradley McGregor, Jens Bedke, Yohann Loriot, Eiji Kikuchi, Jun Guo, Benjamin Garmezy, Srikala S Sridhar and 8 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Future oncology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Review
  2. Review
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

18 authors.

Matthew D GalskyDepartment of Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0001-7655-9378
Alexandra DrakakiDepartment of Medical Oncology, UCLA Health, Los Angeles, CA, USA.ORCID 0000-0001-8865-3548
Arnab BasuDepartment of Oncology, Mayo Clinic, Jacksonville, FL, USA.ORCID 0000-0002-8678-3880
Bradley McGregorDepartment of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.ORCID 0000-0002-8298-0289
Jens BedkeDepartment of Urology & Transplantation Surgery, Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Germany.ORCID 0000-0003-2778-3108
Yohann LoriotDepartment of Oncology, Gustave Roussy Cancer Institute, Paris, France.ORCID 0000-0002-8338-1739
Eiji KikuchiDepartment of Urology, St. Marianna University School of Medicine, Kawasaki, Japan.ORCID 0000-0002-1624-6676
Jun GuoDepartment of Oncology, Peking University Cancer Hospital and Research Institute, Beijing, China.
Benjamin GarmezyDepartment of Genitourinary Cancer Research, Sarah Cannon Research Institute, Nashville, TN, USA.ORCID 0000-0003-2790-6235
Srikala S SridharDivision of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.ORCID 0000-0002-6994-1285
Parminder SinghDepartment of Genitourinary Oncology, Mayo Clinic Arizona, Phoenix, AZ, USA.
Vadim S KoshkinDivision of Hematology/Oncology, Department of Medicine, University of California San Francisco, Helen Diller Family Comprehensive Cancer, San Francisco, CA, USA.ORCID 0000-0003-2277-8668
Mark FlemingDepartment of Medical Oncology, Virginia Oncology Associates, Brock Cancer Center, Norfolk, VA, USA.
Gunnar KlaussDepartment of Global Oncology Research & Development, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Daisy LinDepartment of Clinical Science Therapeutic Area Oncology, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Chelsea LiuDepartment of Biostatistics & Data Management, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Andrea B ApoloDepartment of Oncology, National Cancer Institute, Bethesda, MD, USA.ORCID 0000-0001-9409-1836
Thomas PowlesCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK.ORCID 0000-0001-7760-4724

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enfortumab vedotin (EV) plus pembrolizumab is the first-line standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). However, randomized data to guide treatment after progression on EV plus pembrolizumab are limited. Datopotamab deruxtecan (Dato-DXd), a trophoblast cell surface antigen 2-directed antibody-drug conjugate, has demonstrated durable efficacy and a manageable safety profile in patients with la/mUC. TROPION-Urothelial03 is a global, multicenter, randomized, open-label, phase II/III trial comparing the efficacy and safety of Dato-DXd plus platinum chemotherapy versus gemcitabine plus platinum chemotherapy in patients with la/mUC and disease progression on or after EV plus pembrolizumab. In Part A (phase II), ~60 patients will be randomized 1:1 to Dato-DXd 4 or 6 mg/kg plus platinum chemotherapy to determine optimal dosing. In Part B (phase III), ~570 patients will be randomized 1:1 to receive Dato-DXd at the recommended phase III dose plus platinum chemotherapy or gemcitabine plus platinum chemotherapy. The primary endpoint of Part A is objective response rate (ORR); the dual primary endpoints of Part B are progression-free survival (PFS) by blinded independent central review (BICR) and overall survival. Secondary endpoints include duration of response by investigator (Part A), and PFS by investigator and ORR by BICR and investigator (Part B).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellImmunoconjugatesUrologic NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabineHumansNeoplasm MetastasisAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDeoxycytidineenfortumab vedotinGemcitabineImmunoconjugatesAntibody–drug conjugate (ADC)bladder cancerdatopotamab deruxtecan (Dato-DXd)locally advancedmetastaticplatinum-based chemotherapytrophoblast cell surface antigen 2 (TROP2)urothelial carcinoma

Identifiers

PMID42142358
PMCPMC13203067

What OpenQuestion holds

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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.