Evidence map›Paper›PMID 38652877›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2- and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study.

Aditya Bardia, Ian E Krop, Takahiro Kogawa, Dejan Juric, Anthony W Tolcher, Erika P Hamilton, Toru Mukohara, Aaron Lisberg, Toshio Shimizu, Alexander I Spira and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03401385 (Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors), which is not on this map. Cited by 123 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 4 pooled it
31.9field-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.

NCT03401385 phase1active not recruitingnot on this map

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2018 to 2027Enrolled890ConditionsHormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung CancerArmsDatopotamab Deruxtecan (Dato-DXd), Steroid Containing Mouthwash, Non-Steroid Containing Mouthwash
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Pooled it
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  7. Patritumab deruxtecan in HRNature medicine · 2025
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  13. The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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63 more citing papers are in PubMed but not listed here.

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 at 15 institutions in 3 countries.

Aditya BardiaDepartment of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.ORCID 0000-0003-4885-1157
Ian E KropYale Cancer Center, New Haven, CT.ORCID 0000-0002-6380-5944
Takahiro KogawaDepartment of Advanced Medical Development, Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0003-3730-6591
Dejan JuricDepartment of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.ORCID 0000-0003-2983-7704
Anthony W TolcherSouth Texas Accelerated Research Therapeutics, San Antonio, TX.ORCID 0000-0002-6322-9721
Erika P HamiltonSarah Cannon Research Institute, Nashville, TN.ORCID 0000-0002-1911-0336
Toru MukoharaDepartment of Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-8573-418X
Aaron LisbergDepartment of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA.ORCID 0000-0003-3048-4352
Toshio ShimizuDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0001-6632-0638
Alexander I SpiraVirginia Cancer Specialists (VCS) Research Institute, Fairfax, VA.ORCID 0000-0003-1303-0447
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.ORCID 0000-0002-6260-6943
Senthil DamodaranDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-2470-0891
Kyriakos P PapadopoulosClinical Research, START, San Antonio, TX.ORCID 0000-0002-0667-2620
Jonathan GreenbergGlobal Oncology Clinical Development, Daiichi Sankyo, Inc, Basking Ridge, NJ.
Fumiaki KobayashiData Intelligence, Daiichi Sankyo, Co, Ltd, Tokyo, Japan.
Hong Zebger-GongGlobal Oncology Clinical Development, Daiichi Sankyo Europe GmbH, Munich, Germany.
Rie WongGlobal Oncology Clinical Development, Daiichi Sankyo, Co, Ltd, Tokyo, Japan.
Yui KawasakiGlobal Oncology Clinical Development, Daiichi Sankyo, Inc, Basking Ridge, NJ.
Tadakatsu NakamuraData Intelligence, Daiichi Sankyo, Co, Ltd, Tokyo, Japan.
Funda Meric-BernstamDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-6816-6072
Daiichi-Sankyo (Japan) · JPDaiichi Sankyo (Germany) · DEHarvard University · USThe University of Texas MD Anderson Cancer Center · USDaiichi Sankyo (United States) · USNational Cancer Center Hospital East · JPSarah Cannon · USShowa University · JPSouth Texas Accelerated Research Therapeutics · USTexas Oncology · USThe Cancer Institute Hospital · JPUniversity of California, Los Angeles · USVirginia Cancer Specialists · USWakayama Medical University · JPYale Cancer Center · US

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

purposeDatopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a plasma-stable, selectively cleavable linker. PATIENTS AND

methodsTROPION-PanTumor01 (ClinicalTrials.gov identifier: NCT03401385) is a phase I, dose-escalation, and dose-expansion study evaluating Dato-DXd in patients with previously treated solid tumors. The primary study objective was to assess the safety and tolerability of Dato-DXd. Secondary objectives included evaluation of antitumor activity and pharmacokinetics. Results from patients with advanced/metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer (BC) or triple-negative BC (TNBC) are reported.

resultsAt data cutoff (July 22, 2022), 85 patients (HR+/HER2- BC = 41, and TNBC = 44) had received Dato-DXd. The objective response rate by blinded independent central review was 26.8% (95% CI, 14.2 to 42.9) and 31.8% (95% CI, 18.6 to 47.6) for patients with HR+/HER2- BC and TNBC, respectively. The median duration of response was not evaluable in the HR+/HER2- BC cohort and 16.8 months in the TNBC cohort. The median progression-free survival in patients with HR+/HER2- BC and TNBC was 8.3 and 4.4 months, respectively. All-cause treatment-emergent adverse events (TEAEs; any grade, grade ≥3) were observed in 100% and 41.5% of patients with HR+/HER2- BC and 100% and 52.3% of patients with TNBC. Stomatitis was the most common TEAE (any grade, grade ≥3) in both HR+/HER2- BC (82.9%, 9.8%) and TNBC (72.7%, 11.4%) cohorts.

conclusionIn patients with heavily pretreated advanced HR+/HER2- BC and TNBC, Dato-DXd demonstrated promising clinical activity and a manageable safety profile. Dato-DXd is currently being evaluated in phase III studies.

Indexed as

Erb-b2 Receptor Tyrosine KinasesImmunoconjugatesTriple Negative Breast NeoplasmsAdultAgedAntibodies, Monoclonal, HumanizedAntigens, NeoplasmCamptothecinCell Adhesion MoleculesFemaleHumansMiddle AgedReceptors, EstrogenReceptors, ProgesteroneTrastuzumabAntibodies, Monoclonal, HumanizedAntigens, NeoplasmCamptothecinCell Adhesion MoleculesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesReceptors, EstrogenReceptors, ProgesteroneTACSTD2 protein, humanTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID38652877
PMCPMC11210948
OpenAlexW4395027993

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.