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    Association details:
    Biomarker:HER-2 amplification
    Cancer:Solid Tumor
    Drug:erfonrilimab (KN046) (PD-L1 inhibitor, CTLA4 inhibitor) +
    anbenitamab (KN026) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma

    Excerpt:
    ...HER-2 positive defined as a) HER2 IHC 3+; b) HER2 IHC 2+ with HER2 amplification (HER2/CEP17 > 2.0 by ISH method)； c) HER copy number > 6 by next-generation sequencing using tumor tissue or circulating tumor DNA....
    Trial ID:
    HERCKER-01
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SITC 2020
    Title:

    810 Preliminary safety, tolerability and efficacy results of KN026 in combination with KN046 in patients with HER2 aberrated solid tumors

    Published date:
    11/09/2020
    Excerpt:
    The objective response rate in pts with HER2-positive tumors (n = 14 efficacy evaluable pts) was 9/14 (64.3%, 95% CI 35.1~87.2%) and disease control rate 13/14 (92.9%, 95% CI 66.1~99.8%). 4 out of 5 pts with HER2 mutation or low expression achieved SD including one patient with SD for more than 24 weeks. 4 out of 5 pts with HER2 mutation or low expression achieved SD including one patient with SD for more than 24 weeks.
    DOI:
    http://dx.doi.org/10.1136/jitc-2020-SITC2020.0810