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    DRUG:

    TX05 (trastuzumab biosimilar)

    i
    Other names: TX05
    Company:
    Tanvex BioPharma
    Drug class:
    HER2 inhibitor
    Related drugs:
    over3years
    [VIRTUAL] Trial comparing the safety, efficacy and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ early breast cancer (ESMO 2021)
    Treatment included four 3-week cycles of epirubicin and cyclophosphamide followed by four 3-week cycles of paclitaxel and TX05 or TRA. The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin. Secondary endpoints including ORR, safety and immunogenicity were comparable and support the conclusion of biosimilarity.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • paclitaxel • epirubicin • TX05 (trastuzumab biosimilar)
    over3years
    Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov)
    P3, N=809, Completed, Tanvex BioPharma USA, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paclitaxel • epirubicin • TX05 (trastuzumab biosimilar) • cyclophosphamide intravenous
    almost4years
    Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov)
    P3, N=809, Active, not recruiting, Tanvex BioPharma USA, Inc. | Trial primary completion date: Jun 2020 --> Nov 2020
    Clinical • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paclitaxel • epirubicin • TX05 (trastuzumab biosimilar) • cyclophosphamide intravenous
    over4years
    Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov)
    P3, N=809, Active, not recruiting, Tanvex BioPharma USA, Inc. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paclitaxel • epirubicin • TX05 (trastuzumab biosimilar) • cyclophosphamide intravenous