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    BIOMARKER:

    RAS wild-type + HER-2 positive

    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
    12ms
    PRESSING need of precision care in HER2-positive CRC: The ELEPHANT in the room. (PubMed, Clin Cancer Res)
    While dual-HER2 inhibition has shown promising clinical activity in patients with RAS wild-type HER2-positive metastatic colorectal cancer, predictive biomarkers of response/resistance are less well characterized. Activating HER2/RTK/MAPK genomic alterations appear to blunt the clinical benefit of dual anti-HER2 therapy and may hold a potential albeit partial role in patient selection.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive
    1year
    Negative hyper-selection of patients with HER2-positive and RAS wild-type metastatic colorectal cancer receiving dual HER2 blockade: the PRESSING-HER2 study. (PubMed, Clin Cancer Res)
    PRESSING-HER2 panel and HER2 non-amplified status by NGS warrant validation as potential predictive markers in this setting.
    Journal • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
    |
    HER-2 positive • EGFR mutation • BRAF mutation • EGFR amplification • RAS wild-type • RAS wild-type + HER-2 positive • BRAF amplification • EGFR rearrangement
    over1year
    FDA Approval Summary: Tucatinib with trastuzumab for advanced unresectable or metastatic, chemotherapy refractory, HER2 positive RAS wild type colorectal cancer. (PubMed, Clin Cancer Res)
    On January 29, 2023, the FDA granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of patients with unresectable or metastatic RAS wild-type, HER2-positive colorectal cancer who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. This is the first approval for the subset of patients with HER2-positive colorectal cancer. This article summarizes the FDA's thought process and review of data supporting this accelerated approval.
    FDA event • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive
    |
    Herceptin (trastuzumab) • oxaliplatin • irinotecan • Tukysa (tucatinib)
    over1year
    Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, University of Wisconsin, Madison
    New P2 trial • Metastases
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    over1year
    Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study. (PubMed, Lancet Oncol)
    Tucatinib plus trastuzumab had clinically meaningful anti-tumour activity and favourable tolerability. This treatment is the first US Food and Drug Administration-approved anti-HER2 regimen for metastatic colorectal cancer and is an important new treatment option for chemotherapy-refractory HER2-positive metastatic colorectal cancer.
    P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive
    |
    Herceptin (trastuzumab) • Tukysa (tucatinib)
    over1year
    Negative selection of patients (pts) with HER2-positive and RAS wild-type (wt) metastatic colorectal cancer (mCRC) receiving dual HER2 blockade. (ASCO 2023)
    " We conducted a multicentric case-control study to evaluate the negative predictive impact of a panel of candidate genomic alterations of primary resistance (PRESSING-HER panel) in pts with HER2-positive, RAS wt mCRC treated with trastuzumab-based dual HER2 blockade... The combined assessment of HER2 on/off-target alterations and HER2 GCN stratifies patient outcomes to HER2 dual blockade."
    Clinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
    |
    HER-2 positive • EGFR mutation • BRAF mutation • HER-2 mutation • EGFR amplification • RAS wild-type • RAS wild-type + HER-2 positive • HER-2 rearrangement
    |
    FoundationOne® CDx • MSK-IMPACT
    |
    Herceptin (trastuzumab)
    almost2years
    A Study of Tucatinib and Trastuzumab in People With Rectal Cancer (clinicaltrials.gov)
    P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • RAS wild-type • KRAS exon 2 mutation • RAS wild-type + HER-2 positive • KRAS exon 3 mutation • KRAS exon 4 mutation
    |
    Herceptin (trastuzumab) • Tukysa (tucatinib)