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    DRUG:

    QL1209 (pertuzumab biosimilar)

    i
    Other names: QL1209
    Company:
    Qilu Pharma
    Drug class:
    HER2 dimerization inhibitor
    Related drugs:
    21d
    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) • QL1209 (pertuzumab biosimilar)
    10ms
    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) • QL1209 (pertuzumab biosimilar)
    almost2years
    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) • QL1209 (pertuzumab biosimilar)
    over3years
    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) • QL1209 (pertuzumab biosimilar)