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    Association details:
    Biomarker:HER-2 expression
    Cancer:Solid Tumor
    Drug:Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors

    Published date:
    04/05/2024
    Excerpt:
    ...ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Daiichi Sankyo Press Release
    Title:

    ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors

    Published date:
    01/29/2024
    Excerpt:
    ...ENHERTU® (famtrastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive immunohistochemistry [IHC] 3+) solid tumors...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Daiichi Sankyo Press Release
    Title:

    ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers

    Published date:
    08/31/2023
    Excerpt:
    ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

    Excerpt:
    ...has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology...
    Trial ID:
    DESTINY-Breast02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

    Excerpt:
    ...has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3....
    Trial ID:
    DESTINYBreast06
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO Asia 2023
    Title:

    74MO - Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study

    Published date:
    11/27/2023
    Excerpt:
    In all pts, investigator-assessed ORR (95% CI) was 37.1% (31.3, 43.2); mDOR (95% CI) was 11.3 mo (9.6, 17.8); mPFS (95% CI) was 6.9 mo (5.6, 8.0); and mOS (95% CI) was 13.4 mo (11.9, 15.5). In pts with IHC 3+ expression (central; n=75) ORR was 61.3% (49.4, 72.4); mDOR was 22.1 mo (9.6, not reached); mPFS was 11.9 mo (8.2, 13.0); and mOS was 21.1 mo (15.3, 29.6)....We observed durable responses to T-DXd and clinically meaningful PFS and OS in pretreated pts across HER2-expressing tumors, with safety consistent with the known profile. These data support T-DXd as a potential tumor-agnostic treatment in HER2-expressing tumors.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial

    Published date:
    10/23/2023
    Excerpt:
    Our study demonstrates durable clinical benefit, meaningful survival outcomes, and safety consistent with the known profile (including ILD) in pre-treated patients with HER2-expressing tumors receiving T-DXd. Greatest benefit was observed for the IHC 3+ population. These data support the potential role of T-DXd as a tumor-agnostic therapy for patients with HER2-expressing solid tumors.
    DOI:
    10.1200/JCO.23.02005
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    AstraZeneca Press Release
    Title:

    ENHERTU® Demonstrated Clinically Meaningful Progression-Free Survival and Overall Survival Across Multiple HER2 Expressing Advanced Solid Tumors in DESTINY-PanTumor02 Phase 2 Trial

    Published date:
    07/27/2023
    Excerpt:
    Topline results from the primary analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2 expressing advanced solid tumors, two secondary endpoints of the trial.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) interim results.

    Published date:
    06/07/2023
    Excerpt:
    In all 267 pts, the ORR was 37.1% and median DOR (mDOR) was 11.8 mo; in pts with IHC 3+ expression, the ORR was 61.3% and mDOR was 22.1 mo. ORR per cohort is shown in all pts and those with centrally confirmed HER2 IHC 3+ or IHC 2+ expression….This is the first tumor-agnostic global study of T-DXd in a broad range of HER2-expressing solid tumors. T-DXd showed encouraging ORR, particularly in pts with IHC 3+ expression, durable clinical benefit, and a manageable safety profile in this heavily pretreated population. These interim results show T-DXd to be a potential new Tx option for pts with HER2-expressing solid tumors.
    DOI:
    10.1200/JCO.2023.41.17_suppl.LBA3000
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Jpn J Clin Oncol
    Title:

    The efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-expressing solid tumours: a single-arm meta-analysis

    Published date:
    04/27/2023
    Excerpt:
    There were 11 studies including 1349 HER2-expressing patients in this meta-analysis. The pooled ORR was 47.91%, and the pooled DCR was 87.01%. The mPFS and mOS combined were 9.63 and 10.71 months, respectively....Overall, the efficacy of T-DXd in treating HER2-expressing solid tumours is encouraging...
    DOI:
    10.1093/jjco/hyad036
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Daiichi Sankyo Press Release
    Title:

    ENHERTU® Showed Clinically Meaningful and Durable Responses Across Multiple HER2 Expressing Tumor Types in DESTINYPanTumor02 Phase 2 Trial

    Published date:
    03/06/2023
    Excerpt:
    Positive topline results from an analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed treatment with Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) met the pre-specified target for objective response rate (ORR) and demonstrated durable response across multiple HER2 expressing advanced solid tumors in heavily pretreated patients.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2018
    Title:

    Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts.

    Published date:
    05/16/2018
    Excerpt:
    ...enrolls subjects (sbj) with HER2+ breast cancer (BC) post T-DM1, HER2+ gastric cancer (GC) post trastuzumab, HER2 low BC (IHC 1+ or 2+, ISH-), and other HER2-expressing solid tumors (IHC ≥1+)….Overall, RECIST-confirmed overall response rate (ORR) in the evaluable sbj was 81/160 (50.6%) with the highest ORR in HER2+ BC (64.2%)....DS-8201a shows antitumor activity in multiple tumor types with high ORR and durable responses in heavily pretreated sbj.
    DOI:
    10.1200/JCO.2018.36.15_suppl.2501
    Trial ID:
    DS8201-A-J101