^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Hervelous (trastuzumab biosimilar)

    i
    Other names: HD201
    Company:
    Alvogen, Dr. Reddy’s, Hanwha Solutions, Mundipharma, Prestige BioPharma
    Drug class:
    HER2 inhibitor
    Related drugs:
    almost2years
    Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting. (PubMed, BMC Cancer)
    This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.
    Clinical • P3 data • Clinical Trial,Phase III • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    docetaxel • cyclophosphamide • epirubicin • Hervelous (trastuzumab biosimilar)
    2years
    Final analysis of the phase III randomized clinical trial, comparing HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting (ESMO Asia 2022)
    Eligible patients received 4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2 with either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in the neoadjuvant setting and then, 10 cycles of HD201 or referent trastuzumab after surgery, according to their initial randomization. During the post-treatment follow up period, AEs were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the referent trastuzumab groups respectively and no serious event was related to study treatment. Conclusions This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and referent trastuzumab.
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    docetaxel • cyclophosphamide • epirubicin • Hervelous (trastuzumab biosimilar)
    over2years
    Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol)
    Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile. ClinicalTrials.gov Identifier: NCT03013504.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR negative
    |
    Herceptin (trastuzumab) • docetaxel • cyclophosphamide • epirubicin • Hervelous (trastuzumab biosimilar)
    over2years
    TROIKA: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients (clinicaltrials.gov)
    P3, N=503, Completed, Prestige Biopharma Limited | 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
    |
    docetaxel • cyclophosphamide • epirubicin • Hervelous (trastuzumab biosimilar)
    over4years
    [VIRTUAL] A phase III trial to compare the efficacy, safety, pharmacokinetics and immunogenicity of HD201 to trastuzumab in HER2+ early breast cancer patients (TROIKA) (ESMO 2020)
    Methods 503 patients with HER2+ EBC were randomised in a 1:1 ratio to receive either HD201 or Herceptin in neoadjuvant settings for 8 cycles in combination with chemotherapy (4 cycles of docetaxel followed by 4 cycles of epirubicin/cyclophosphamide). Funding: Prestige Biopharma Ltd. Clinical trial identification: Eudract: 2016-004019-11.
    Clinical • P3 data • PK/PD data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    docetaxel • epirubicin • Hervelous (trastuzumab biosimilar)
    over4years
    [VIRTUAL] Establishing analytical and clinical similarity between HD201 and herceptin. (ASCO 2020)
    The overall comparison exercise demonstrated the equivalence of HD201 to Herceptin. Research Funding: Private funding
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Hervelous (trastuzumab biosimilar)
    over4years
    TROIKA: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients (clinicaltrials.gov)
    P3, N=500, Active, not recruiting, Prestige Biopharma Pte Ltd | Trial completion date: Dec 2019 --> Mar 2022 | Trial primary completion date: Dec 2019 --> Apr 2019
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification
    |
    docetaxel • epirubicin • Hervelous (trastuzumab biosimilar) • cyclophosphamide intravenous