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    Association details:
    Biomarker:HER-2 mutation
    Cancer:Non Small Cell Lung Cancer
    Drug:Gilotrif (afatinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Resistant
    Evidence:
    Evidence Level:
    Resistant: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    The NCCN NSCLC panel does not recommend single-agent therapy with trastuzumab or afatinib (both for ERBB2 mutations), because response rates are lower and treatment is less effective when these agents are used for patients with ERBB2 mutations.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Afatinib in NSCLC With HER2 Mutation

    Excerpt:
    ...- Tumour block available for central review of HER2 mutation status....
    Trial ID:
    NICHE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Afatinib in NSCLC With HER2 Mutation

    Excerpt:
    ...- Tumor tissue with HER2 mutations as confirmed by AmoyDx® HER2 Mutation Detection Kit...
    Trial ID:
    NCT02597946
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer

    Excerpt:
    ...Evaluation of the HER-2 gene copy number and amplification`DNA Extraction and Mutational Analysis of EGFR and HER-2`Toxicity evaluation`Determination of plasma HGF pre and post-treatment concentration...
    Less C2 evidence
    Evidence Level:
    Resistant: C3 – Early Trials
    New
    Source:
    J Thorac Oncol
    Title:

    Activity of Afatinib in Heavily Pretreated Patients With ERBB2 Mutation-Positive Advanced NSCLC: Findings From a Global Named Patient Use Program

    Excerpt:
    Twenty-eight heavily pretreated patients in the named patient use program had a documented ERBB2 mutation by local testing. Median time-to-treatment failure (TTF; time from treatment initiation to discontinuation for any reason) was 2.9 months; eight patients (29%) had TTF greater than 1 year. Objective response rate was 19% (3 of 16 patients with response data achieved partial response) and disease control rate (DCR) was 69% (11 of 16).
    DOI:
    10.1016/j.jtho.2018.07.093
    Evidence Level:
    Resistant: C4 – Case Studies
    Source:
    Target Oncol
    Title:

    A Phase 2 Trial of Afatinib in Patients with Solid Tumors that Harbor Genomic Aberrations in the HER family: The MOBILITY3 Basket Study

    Published date:
    05/30/2022
    Excerpt:
    CONTRADICTING EVIDENCE: The MOBILITY3 trial evaluated the antitumor activity of afatinib, an oral pan-HER tyrosine kinase inhibitor (TKI) in HER-aberrant tumors outside of the licensed indications....All 3 patients with salivary gland cancers and 1 patient with ERBB2-mutant NSCLC had clinical benefit (stable disease or partial response lasting > 24 weeks).
    DOI:
    10.1007/s11523-022-00884-z