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    BIOMARKER:

    HER-2 mutation

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    1d
    The role of zongertinib, a highly selective tyrosine kinase inhibitor, in targeting HER2-mutant NSCLC: a bench-to-bedside review. (PubMed, Expert Rev Anticancer Ther)
    Zongertinib is the first oral TKI approved for HER2-mutant NSCLC and will provide patients with a convenient, tolerable and effective treatment option in an area of significant unmet need. Next steps include its potential transition to a first-line setting, identification of additional indications, and development of novel combination regimens.
    Review • Journal • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • EGFR wild-type
    |
    Hernexeos (zongertinib)
    3d
    ERBB2 I655V mutation correlates with efficacy of immunotherapy in gallbladder cancer. (PubMed, World J Surg Oncol)
    The ERBB2 I655V mutation may be associated with improved treatment response to immunotherapy in gallbladder cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TYK2 (Tyrosine Kinase 2)
    |
    PD-L1 expression • HER-2 overexpression • HER-2 mutation
    |
    Focus V (anlotinib) • AiRuiKa (camrelizumab)
    3d
    Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, SystImmune Inc. | Trial completion date: Aug 2027 --> Apr 2029 | Trial primary completion date: Dec 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    4d
    ERBB2 mutations promote recurrence and metastasis in non-muscle-invasive bladder cancer via HIF-1 phosphorylation: Insights from whole exome sequencing. (PubMed, J Pharm Anal)
    In vivo studies using mouse models further supported these findings, showing that ERBB2 mutations promote tumor growth, metastasis, and macrophage infiltration. Collectively, these results suggest that ERBB2 mutations drive NMIBC progression by stabilizing HIF-1 through phosphorylation, thereby facilitating tumor development and immune modulation, and underscore the potential of ERBB2 as a therapeutic target for preventing NMIBC recurrence and metastasis.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    HER-2 mutation
    6d
    Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of Guangzhou Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    6d
    Trastuzumab rezetecan alone or in combination with adebrelimab in advanced solid tumors with HER2 expression or mutation: a prospective, multicenter, open, nonrandomized, multicohort study. (ChiCTR2500113763)
    P=N/A, N=200, Not yet recruiting, The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    6d
    Trastuzumab rezetecan (SHR-A1811) combined with bevacizumab in previously treated HER2-altered non-small-cell lung cancer: a phase 2, single-arm study. (ChiCTR2500113565)
    P2, N=60, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Science; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    6d
    SHR-A1811 plus QL1706 versus standard therapy as first-line treatment for locally advanced or metastatic HER2-overexpressing non-small cell lung cancer: an open-label, single-arm, phase II clinical trial (ChiCTR2500114106)
    P2, N=39, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • EGFR mutation • HER-2 overexpression • HER-2 mutation • ALK mutation • HER-2 positive + HER-2 overexpression
    |
    trastuzumab rezetecan (SHR-A1811) • Qibeian (iparomlimab/tuvonralimab)
    6d
    Glumetinib combined with platinum-based chemotherapy for the treatment of MET-overexpressing locally advanced or metastatic non-small cell lung cancer: A single-arm, multicenter study (ChiCTR2600117342)
    P1, N=48, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • 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 • BRAF mutation • BRAF V600 • HER-2 mutation • RET fusion • MET overexpression • HER-2 exon 20 insertion • ALK fusion • RET mutation • ROS1 fusion • MET mutation • NTRK fusion
    |
    carboplatin • pemetrexed • Haiyitan (gumarontinib)
    8d
    Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov)
    P1/2, N=315, Active, not recruiting, Dizal Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)
    8d
    Trastuzumab Deruxtecan in Non-Breast Solid Tumors: Expanding Indications, Efficacy, and Future Directions. (PubMed, Crit Rev Oncol Hematol)
    T-DXd has emerged as a transformative therapy across HER2-driven malignancies, leading to histology-specific and tissue-agnostic approvals. Vigilant ILD monitoring is essential, and further research is warranted to refine biomarkers, address resistance, and explore rational drug combinations. T-DXd exemplifies the paradigm shift of antibody-drug conjugates toward pan-cancer precision oncology.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    10d
    Prognostic Impact of RTK-RAS Alterations in FOLFOX-Treated Early-Onset Colorectal Cancer Revealed by Artificial Intelligence-Driven Precision Oncology. (PubMed, Cancers (Basel))
    RTK-RAS pathway alterations demonstrate strong age-, ancestry-, and treatment-specific prognostic effects and may serve as precision biomarkers of differential chemotherapy response. AI-enabled analytics substantially accelerated integrative biomarker discovery, supporting their utility for advancing precision oncology in EOCRC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NF1 (Neurofibromin 1) • ERRFI1 (ERBB Receptor Feedback Inhibitor 1) • MAPK3 (Mitogen-Activated Protein Kinase 3)
    |
    KRAS mutation • HER-2 mutation
    |
    5-fluorouracil • leucovorin calcium