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    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:
    5d
    A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=66, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • Datroway (datopotamab deruxtecan-dlnk) • Yidafan (ivonescimab)
    6d
    Exposure-Response Analyses of Datopotamab Deruxtecan (Dato-DXd) in Patients with Hormone Receptor (HR) Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer. (PubMed, J Clin Pharmacol)
    Exposure-safety analysis further supported that this approach may reduce the potential associated safety risks. These results support the recommended Dato-DXd dosing regimen (6 mg/kg Q3W with dose capping for patients ≥90 kg) and highlight its favorable benefit-risk profile in patients with HR+/HER2-breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Datroway (datopotamab deruxtecan-dlnk)
    7d
    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=400, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    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)
    17d
    Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. (PubMed, Ann Oncol)
    Dato-DXd demonstrated significantly improved PFS and OS versus chemotherapy in patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. Safety was consistent with the known profile for Dato-DXd.
    P3 data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    Datroway (datopotamab deruxtecan-dlnk)
    28d
    Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial. (PubMed, J Thorac Oncol)
    Dato-DXd plus pembrolizumab therapy (with and without Pt-CT) exhibited appreciable safety and durable antitumor activity across PD-L1 expression levels in patients with amNSCLC.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Datroway (datopotamab deruxtecan-dlnk)
    29d
    Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) (clinicaltrials.gov)
    P3, N=605, Active, not recruiting, Daiichi Sankyo | Trial completion date: Jan 2026 --> Feb 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET exon 14 mutation
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    1m
    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=400, Recruiting, AstraZeneca | N=103 --> 400
    Enrollment change • Trial initiation date
    |
    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)
    |
    KRAS G12C • MET exon 14 mutation • KRAS G12
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    1m
    Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (clinicaltrials.gov)
    P2, N=454, Recruiting, AstraZeneca | Trial completion date: Aug 2026 --> Oct 2027 | Trial primary completion date: Aug 2026 --> Oct 2027
    Trial completion date • Trial primary completion date • Pan tumor
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • 5-fluorouracil • capecitabine • prednisone • Datroway (datopotamab deruxtecan-dlnk) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    1m
    Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (clinicaltrials.gov)
    P2, N=137, Completed, Daiichi Sankyo | Active, not recruiting --> Completed
    Trial completion
    |
    EGFR (Epidermal growth factor receptor) • 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 mutation • EGFR mutation • MET exon 14 mutation
    |
    Datroway (datopotamab deruxtecan-dlnk)
    1m
    TROPION-Lung10: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=675, Recruiting, AstraZeneca | Trial completion date: May 2030 --> Dec 2029 | Trial primary completion date: Apr 2028 --> Dec 2029
    Trial completion date • Trial primary completion date • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • Datroway (datopotamab deruxtecan-dlnk) • rilvegostomig (AZD2936)
    1m
    Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=45, Recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Trodelvy (sacituzumab govitecan-hziy) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan)