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    Association details:
    Biomarker:EGFR exon 20 insertion
    Cancer:Non Small Cell Lung Cancer
    Drug:PH001 (EGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

    Excerpt:
    ...Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (China sites) or an accredited (outside of the US) local laboratory....
    Trial ID:
    NCT05767892
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Thorac Oncol
    Title:

    Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial

    Published date:
    10/01/2023
    Excerpt:
    YK-029A showed manageable safety and was tolerable in patients with NSCLC harboring EGFR mutations and showed promising antitumor activity in untreated patients with EGFR ex20ins mutations.
    DOI:
    10.1016/j.jtho.2023.09.1449
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Safety and preliminary efficacy of YK-029A, a novel EGFR TKI, in patients with advanced NSCLC harboring ex20ins, T790M or rare mutations.

    Published date:
    05/25/2023
    Excerpt:
    Treatment-naïve ex20ins cohort (200 mg) (N=26)...Objective response rate...73.1% (95% CI, 52.21% to 88.43%)...YK-029A was well tolerated and showed preliminary efficacy in treatment-naïve EGFR ex20ins mutant patients with locally advanced or metastatic NSCLC.
    DOI:
    10.1200/JCO.2023.41.16_suppl.9014
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Eur J Med Chem
    Title:

    Discovery of YK-029A, a novel mutant EGFR inhibitor targeting both T790 M and exon 20 insertion mutations, as a treatment for NSCLC

    Published date:
    07/05/2023
    Excerpt:
    ...YK-029A exhibited significant antitumor activity in EGFRex20ins-driven patients-derived xenograft (PDX) models, preventing tumor progression or causing tumor regression at well-tolerated dosages.
    DOI:
    10.1016/j.ejmech.2023.115590