^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Datroway (datopotamab deruxtecan-dlnk)

    i
    Other names: DS-1062a, DS-1062, DS 1062, Dato-DXd, Dato DXd, DS 1062a, DS1062a, DS1062, DatoDXd
    Company:
    AstraZeneca, Daiichi Sankyo
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
    2d
    Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC post-progression on first-line osimertinib: ORCHARD. (PubMed, Ann Oncol)
    Osimertinib plus Dato-DXd demonstrated clinical benefit in patients with EGFR-mutated advanced NSCLC who progressed on first-line osimertinib. AEs in the 6 mg/kg cohort were of higher frequency and severity but could be managed with prophylaxis, careful monitoring and dose reduction. The safety profile was consistent with the known profiles of the individual drugs. Considering the overall benefit-risk profile, 6 mg/kg is suggested as the preferred Dato-DXd starting dose for combining with osimertinib 80 mg.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • Datroway (datopotamab deruxtecan-dlnk)
    2d
    TROPION-Lung17: Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=82, Recruiting, AstraZeneca
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    KRAS G12C • MET exon 14 mutation • KRAS G12
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    3d
    PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease (clinicaltrials.gov)
    P2, N=78, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Datroway (datopotamab deruxtecan-dlnk)
    5d
    D763QC00001: A trial to learn how effective and safe datopotamab deruxtecan (Dato-DXd) is compared to docetaxel and how well Dato-DXd works in adults with advanced or metastatic TROP2-positive, non-squamous non-small cell lung cancer (NS-NSCLC). (2024-520101-39-00)
    P2/3, N=13, Not yet recruiting, AstraZeneca AB
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS G12C • MET exon 14 mutation • KRAS G12
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    9d
    D516KC00001: A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib (2024-511362-37-00)
    P2/3, N=200, Recruiting, AstraZeneca AB | Active, not recruiting --> Recruiting
    Enrollment open
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
    9d
    1011098: An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer (2024-519913-76-00)
    P1/2, N=80, Recruiting, Queen Mary University Of London | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan-dlnk)
    10d
    What practicing pathologists and oncologists should know about the new computational pathology-based companion diagnostic tools. (PubMed, J Pathol)
    The TROPION-PanTumor01 trial recently demonstrated the superiority of a supervised machine learning model (termed the quantitative continuous score [QCS] by the vendor) in assessing TROP2 IHC compared with human scoring, promising better stratification of patients with non-small cell lung cancer for treatment with datopotamab deruxtecan..
    Journal • Companion diagnostic • IO Companion diagnostic • PD(L)-1 Biomarker • IO biomarker • PD(L)-1 companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    Datroway (datopotamab deruxtecan-dlnk)
    15d
    Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) (clinicaltrials.gov)
    P3, N=1170, Active, not recruiting, Daiichi Sankyo | Trial completion date: Aug 2027 --> May 2029 | Trial primary completion date: Aug 2027 --> May 2029
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
    16d
    Quantitative Assays for TROP2 Measurement in Breast Cancer and Comparison to H-Score. (PubMed, Appl Immunohistochem Mol Morphol)
    With the recent FDA-approval of sacituzumab govitecan and datopotamab deruxtecan in breast cancer, TROP2-targeting therapies showed promising clinical outcomes. This work represents only analytic validation, but work on clinical validation has begun. In the future, this assay may help identify patients who are more likely to benefit from TROP2-targeted therapies.
    Journal
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    Trodelvy (sacituzumab govitecan-hziy) • Datroway (datopotamab deruxtecan-dlnk)
    17d
    Tuxedo-2: Phase II Study of daTopotamab-derUXtecan (Dato-DXd; DS-1026a) in triple-negative brEast cancer patients with newly Diagnosed or prOgressing brain metastases (2024-518819-19-00`2022-003203-14)
    P1/2, N=26, Recruiting, Medical University Of Vienna
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Datroway (datopotamab deruxtecan-dlnk)
    17d
    DS1062-328: Dato-DXd plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Previously Treated la/mUC. (2024-516906-47-00)
    P2/3, N=341, Recruiting, Daiichi Sankyo Inc.
    New P2/3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Padcev (enfortumab vedotin-ejfv) • Datroway (datopotamab deruxtecan-dlnk)
    17d
    D9260C00003: A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer (2025-521904-23-00)
    P1/2, N=50, Not yet recruiting, AstraZeneca AB
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive • PGR positive
    |
    Datroway (datopotamab deruxtecan-dlnk)