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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:
    1d
    TROPION Lung15: A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=744, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: May 2028 --> Sep 2028 | Trial primary completion date: Jun 2026 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
    4d
    Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan. (PubMed, Ann Pharmacother)
    Dato-DXd offers a promising treatment option for heavily pretreated patients with HR+/HER2- breast cancer and EGFR-mutant NSCLC, providing meaningful clinical benefit with a manageable safety profile. Optimal sequencing and positioning within the rapidly shifting ADC landscape requires further investigation.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    8d
    ICARUS-LUNG01: Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Trial primary completion date: Sep 2025 --> Apr 2028
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • 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)
    |
    EGFR mutation • BRAF mutation • RET mutation • MET mutation • NTRK fusion
    |
    Datroway (datopotamab deruxtecan-dlnk)
    8d
    TB06: A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer (clinicaltrials.gov)
    P3, N=100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Datroway (datopotamab deruxtecan-dlnk)
    10d
    CERTIS1: Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (clinicaltrials.gov)
    P1/2, N=695, Recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Aug 2027 | Trial primary completion date: Apr 2027 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • HRD (Homologous Recombination Deficiency) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation
    |
    temozolomide • Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk) • AZD9574
    10d
    CLN-619-001: A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=440, Active, not recruiting, Cullinan Therapeutics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • CLN-619
    15d
    DIAMOND: Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=140, Recruiting, Queen Mary University of London | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan-dlnk)
    16d
    Inhibiting TROP2 in advanced non-small-cell lung cancer with sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan: similarities and differences. (PubMed, Cancer Chemother Pharmacol)
    There are differences in pharmacological effects, efficacy, and incidence of adverse events among sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan. For patients with EGFR-mutated progression after targeted therapy or driver gene negative advanced non-small cell lung cancer, the individualized optimization of TROP2 ADCs treatment can obtain the greatest benefit.
    Review • Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Trodelvy (sacituzumab govitecan-hziy) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan)
    1m
    A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) (clinicaltrials.gov)
    P3, N=644, Active, not recruiting, AstraZeneca | Trial primary completion date: Dec 2025 --> Aug 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    PD-L1 expression • PD-L1 negative
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • Datroway (datopotamab deruxtecan-dlnk)
    1m
    Datopotamab deruxtecan: a new era in targeted therapy for metastatic breast cancer. (PubMed, Ann Med Surg (Lond))
    With better efficacy than conventional treatments, it offers a possible alternative for individuals who have not responded to previous endocrine or chemotherapy therapies. This manuscript reviews the mechanisms of action, clinical efficacy, safety profiles, and trials of Dato-DXd and T-DXd, highlighting their transformative potential and positioning in current breast cancer treatment algorithms.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk)
    1m
    Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM (clinicaltrials.gov)
    P2, N=60, Recruiting, Brown University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Datroway (datopotamab deruxtecan-dlnk)
    1m
    First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) (clinicaltrials.gov)
    P1, N=890, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • Pan tumor • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CD4 (CD4 Molecule) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 expression
    |
    Datroway (datopotamab deruxtecan-dlnk)