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    DRUG:

    Ansaizhu (pertuzumab biosimilar)

    i
    Other names: QL1209, QL 1209, QL-1209
    Company:
    Qilu Pharma
    Drug class:
    HER2 dimerization inhibitor
    Related drugs:
    1m
    Multiomic factor analysis for pathologic complete response after pembrolizumab + trastuzumab + pertuzumab in HER2-enriched early breast cancer: WSG-Keyriched-1 trial. (PubMed, Clin Cancer Res)
    Our multiomic analysis uncovered mechanisms of tumor response to immunotherapy combined with dual HER2 blockade. These results could inform the design of larger trials investigating chemotherapy-free regimens in selected patients with HER2+ eBC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CD36 (thrombospondin receptor)
    |
    Keytruda (pembrolizumab) • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)
    9ms
    A Study of QLS1209 in theTreatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=149, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1 trial
    |
    Ansaizhu (pertuzumab biosimilar)
    over1year
    QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial. (PubMed, Br J Cancer)
    QL1209 demonstrated equivalent efficacy and comparable safety profile to the reference pertuzumab in neoadjuvant treatment of HER2-positive, ER/PR-negative, early, or locally advanced breast cancer.
    Clinical • P3 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)
    over1year
    Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel. (clinicaltrials.gov)
    P3, N=517, Completed, Qilu Pharmaceutical Co., Ltd. | Not yet recruiting --> Completed | Trial completion date: Dec 2022 --> Oct 2023
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 amplification • PGR negative
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)
    over2years
    Neoadjuvant QL1209 (a pertuzumab biosimilar) compared with pertuzumab plus trastuzumab and docetaxel in early or locally advanced, HER2-positive, ER(-)/PR(-) breast cancer: A multicenter, randomized, double-blind, equivalence, phase III study (ESMO 2023)
    Incidences of ADA and Nab were similar between 2 groups (2.3% vs 3.1%; 0.8% vs 0.8%). Table: 245P Conclusions QL1209 demonstrated equivalence to P in efficacy and showed comparable safety profile and immunogenicity in patients with early or locally advanced HER2-positive breast cancer.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)
    over3years
    Rare ocular toxicity induced by pertuzumab/QL1209 in healthy chinese subjects: case reports and whole-exome sequencing analysis. (PubMed, Invest New Drugs)
    In summary, this is the first report describing the occurrence of ocular toxicity induced by pertuzumab in the Chinese population and exploring the possible genetic mechanisms. These findings could provide evidence for clinicians to raise concerns about the risk of ocular toxicity with the clinical use of pertuzumab.
    Journal
    |
    mTOR (Mechanistic target of rapamycin kinase) • IRS2 (Insulin receptor substrate 2) • CDH23 (Cadherin Related 23) • RBM24 (RNA Binding Motif Protein 24)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)
    5years
    Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel. (clinicaltrials.gov)
    P3, N=544, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    Clinical • New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 amplification • PGR negative
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar)