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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:
    19h
    LIBRA: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=278, Recruiting, AstraZeneca | Trial primary completion date: Mar 2027 --> Apr 2029
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    ALK rearrangement
    |
    Cyramza (ramucirumab) • Datroway (datopotamab deruxtecan-dlnk) • rilvegostomig (AZD2936)
    2d
    A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) (clinicaltrials.gov)
    P3, N=732, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jul 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Datroway (datopotamab deruxtecan-dlnk)
    8d
    Oral mucositis secondary to datopotamab deruxtecan for advanced-stage cancer managed with cryotherapy after topical steroid failure: A case series study. (PubMed, J Am Dent Assoc)
    These findings highlight the need for larger, prospective studies to define optimal management strategies for ADC-induced OM.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Datroway (datopotamab deruxtecan-dlnk)
    10d
    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 completion date: Dec 2025 --> Nov 2028
    Trial 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)
    10d
    TROPION-Lung12: A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features (clinicaltrials.gov)
    P3, N=24, Active, not recruiting, AstraZeneca | N=660 --> 24 | Trial completion date: Jan 2035 --> Jun 2027 | Trial primary completion date: May 2033 --> Jun 2027 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    cisplatin • carboplatin • pemetrexed • etoposide IV • vinorelbine tartrate • Datroway (datopotamab deruxtecan-dlnk) • rilvegostomig (AZD2936)
    15d
    TROPION-SWISH: An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P4, N=100, Not yet recruiting, AstraZeneca
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    dexamethasone • Datroway (datopotamab deruxtecan-dlnk)
    24d
    TROPION-Breast05: A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=625, Recruiting, AstraZeneca | Trial completion date: Apr 2029 --> Sep 2030 | Trial primary completion date: Oct 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Datroway (datopotamab deruxtecan-dlnk)
    25d
    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 | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    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)
    25d
    An overview of recent advancements in targeted cancer therapies and their potential clinical impact. (PubMed, RSC Med Chem)
    The success of inhibitors like sotorasib and adagrasib has expanded options for targeting once 'undruggable' oncogenic drivers such as KRAS...ADCs such as EMRELIS™, Datroway, and ELAHERE™ offer precise targeting along with potent cytotoxic agents...Cancer vaccine research is progressing with licensed immunoprophylactic drugs, and AI tools like AlphaFold are speeding up drug discovery by enhancing structural biology predictions. This review covers recent cancer therapeutics advancements, including targeted inhibitors, immunotherapies, resistance strategies, epigenetic interventions, combination therapies, vaccines, and AI applications.
    Review • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • Elahere (mirvetuximab soravtansine-gynx) • Datroway (datopotamab deruxtecan-dlnk) • Emrelis (telisotuzumab vedotin-tllv)
    28d
    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, Recruiting, AstraZeneca | 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) • simmitinib (SYHA1817)
    28d
    Targeting common EGFR mutations in NSCLC-review of global phase III trials of third-generation inhibitors. (PubMed, J Natl Cancer Inst)
    The addition of osimertinib to curative-intent strategies have demonstrated improvements in disease-free survival and overall survival (OS) as adjuvant therapy in resected stage IB-IIIa patients, major pathological responses compared to chemotherapy when used as neoadjuvant therapy, and progression-free survival (PFS) compared to placebo when used as consolidation therapy in unresectable stage III patients. Currently, subsequent treatment recommendations include chemotherapy or datopotamab deruxtecan following progression on a third-generation EGFR-TKI combination and amivantamab plus platinum-based chemotherapy following progression on monotherapy. The treatment landscape for NSCLC with common EGFR mutations is rapidly evolving and third-generation EGFR-TKIs play an integral role in both the curative-intent and palliative settings.
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • Datroway (datopotamab deruxtecan-dlnk) • simmitinib (SYHA1817)
    1m
    TROPION-Lung15: a randomized phase III study of osimertinib combined with datopotamab deruxtecan (Dato-DXd) or Dato-DXd alone versus platinum-doublet chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer and whose disease has progressed on prior osimertinib. (PubMed, Ther Adv Med Oncol)
    Data from this study could lead to a new treatment option in this setting. ClinicalTrials.gov identifier: NCT06417814 (date of registration: May 13, 2024).
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • Datroway (datopotamab deruxtecan-dlnk)