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    Association details:
    Biomarker:HER-2 mutation
    Cancer:Solid Tumor
    Drug:Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

    Excerpt:
    AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

    Excerpt:
    ...- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA...
    Trial ID:
    DESTINY-Lung04
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

    Excerpt:
    ...o Has a history of Her2 expression or activating Her2-mutation...
    Trial ID:
    NCT06058988
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

    Excerpt:
    ...- For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent....
    Trial ID:
    DESTINY-Lung01
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

    Excerpt:
    ...- Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing....
    Trial ID:
    DESTINY-Lung05
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

    Excerpt:
    ...- Pathologically documented metastatic NSCLC with a known activating HER2 mutation....
    Trial ID:
    DESTINY-LUNG02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

    Excerpt:
    ...Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which...
    Trial ID:
    DS8201-A-J101
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2023
    Title:

    654O - Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with solid tumors harboring specific HER2-activating mutations (HER2m): Primary results from the international phase II DESTINY-PanTumor01 (DPT-01) study

    Published date:
    10/16/2023
    Excerpt:
    DPT-01 is the first tumor-agnostic global study of T-DXd in a range of solid tumors with prespecified HER2m. In heavily pretreated pts with limited Tx options, T-DXd demonstrated encouraging anticancer activity and long DoR across multiple tumor types with HER2m.
    Trial ID:
    DESTINY-PanTumor01