Evidence map›Paper›PMID 40728126›Full record

ArticleFuture oncology (London, England)2025

SGNDV-001: disitamab vedotin with pembrolizumab in HER2-expressing locally advanced or metastatic urothelial carcinoma.

Thomas B Powles, Enrique Grande, Nimira Alimohamed, Niara Oliveira, Srikala S Sridhar, Alexandra Drakaki, Ravindran Kanesvaran, Yohann Loriot, Andrea Necchi, Sonia Franco and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05911295 (An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

NCT05911295 phase3active not recruitingnot on this map

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

TypeinterventionalSponsorSeagen, a wholly owned subsidiary of PfizerRan2023 to 2029Enrolled412ConditionsUrothelial CarcinomaArmsdisitamab vedotin, pembrolizumab, gemcitabine, cisplatin, carboplatin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. 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

14 authors.

Thomas B PowlesBarts Cancer Centre, Queen Mary University of London, London, UK.
Enrique GrandeDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Nimira AlimohamedDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.
Niara OliveiraMater Hospital Brisbane, Mater Misericordiae, and the School of Clinical Medicine, Mater Clinical Unit, University of Queensland, Brisbane, Australia.
Srikala S SridharDivision of Medical Oncology, University of Toronto, Princess Margaret Cancer Center, Toronto, ON, Canada.
Alexandra DrakakiDivision of Hematology/Oncology, David Geffen School of Medicine, Los Angeles, CA, USA.
Ravindran KanesvaranDivision of Medical Oncology, National Cancer Center Singapore, Singapore, Singapore.
Yohann LoriotDepartment of Cancer Medicine, Institut de Cancérologie Gustave Roussy, Villejuif, France.
Andrea NecchiDepartment of Medical Oncology, Vita-Salute San Raffaele University IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy.
Sonia FrancoMerck & Co, Inc, Rahway, NJ, USA.
Dingfeng JiangPfizer Oncology, Pfizer Inc, South San Francisco, CA, USA.
Kristel ApolinarioPfizer Oncology, Pfizer Inc, South San Francisco, CA, USA.
Wei ZhangPfizer Oncology, Pfizer Inc, South San Francisco, CA, USA.
Matthew D GalskyDivision of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPlatinum-based chemotherapy for the treatment of locally advanced or metastatic urothelial carcinoma (la/mUC), has been the first-line standard of care for many decades. Enfortumab vedotin, an antibody-drug conjugate, combined with pembrolizumab, a programmed death 1 (PD-1) inhibitor, recently demonstrated improved efficacy versus chemotherapy in la/mUC. Since 60%-80% of patients with UC have tumors expressing human epidermal growth factor receptor 2 (HER2), HER2-directed vedotin-based antibody-drug conjugates may also be beneficial in la/mUC. PATIENTS AND

methodsThe phase 3 trial SGNDV-001 (C5731001; NCT05911295) is evaluating disitamab vedotin (HER2-directed antibody-drug conjugate) with pembrolizumab compared with chemotherapy in treatment-naive patients with HER2-expressing la/mUC. Dual primary endpoints are progression-free survival (per blinded independent central review) and overall survival. Potential synergistic effects of disitamab vedotin and pembrolizumab could establish this combination as a novel therapeutic option for HER2-expressing la/mUC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellErb-b2 Receptor Tyrosine KinasesImmunoconjugatesUrinary Bladder NeoplasmsUrologic NeoplasmsAntibodies, MonoclonalClinical Trials, Phase III as TopicFemaleHumansMulticenter Studies as TopicOligopeptidesRandomized Controlled Trials as TopicAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeddisitamab vedotinenfortumab vedotinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesOligopeptidespembrolizumabAntibody-drug conjugatedisitamab vedotinHER2metastaticPD-1pembrolizumaburothelial cancer

Identifiers

PMID40728126
PMCPMC12407659

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.