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    DRUG:

    Herwenda (trastuzumab biosimilar)

    i
    Other names: EG12014, EGI014, EGI014A1
    Company:
    EirGenix, Sandoz
    Drug class:
    HER2 inhibitor
    Related drugs:
    over1year
    A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors. (ASCO 2023)
    BDC-1001 incorporates a trastuzumab biosimilar (EG12014) conjugated to a proprietary TLR7/8 agonist using a non-cleavable linker and a cell membrane-impermeable payload. An international phase 1/2 study was initiated to evaluate the safety of BDC-1001 ± nivolumab (nivo) and to identify the recommended phase 2 dose (RP2D) considering PK/PD analyses and preliminary efficacy... BDC-1001 mono and combo were well-tolerated. Targeted serum exposure levels were achieved, and encouraging clinical activity was noted in heavily pretreated pts with various HER2 positive tumors, especially in the 20 mg/kg q2w cohorts. Immune biomarker changes from plasma and tumor were consistent with MoA of this ISAC.
    Clinical • P1/2 data • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001) • Herwenda (trastuzumab biosimilar)
    almost2years
    EGC002: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=807, Completed, EirGenix, Inc. | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • cyclophosphamide • Herwenda (trastuzumab biosimilar)
    almost2years
    A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with Herceptin® as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2-positive Early Breast Cancer (EBCC 2022)
    Neoadjuvant phase: 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintece dose: 6 mg/kg) and paclitaxel (175 mg/m2) every 3 weeks for 4 cycles. This study demonstrated that EG12014, a proposed trastuzumab biosimilar, matches reference trastuzumab in terms of efficacy, safety, PK and immunogenicity.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • HER-2 overexpression • HER-2 amplification • PGR negative
    |
    Herceptin (trastuzumab) • paclitaxel • cyclophosphamide • epirubicin • Herwenda (trastuzumab biosimilar)
    over2years
    EGC002: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=807, Active, not recruiting, EirGenix, Inc. | Unknown status --> Active, not recruiting | Trial completion date: Jan 2022 --> Sep 2022
    Enrollment closed • Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • cyclophosphamide • Herwenda (trastuzumab biosimilar)
    3years
    A phase III, randomized, multicenter, double-blind study to compare efficacy and safety of EG12014 (EirGenix trastuzumab) with Herceptin ® as neoadjuvant treatment in combination with anthracycline/paclitaxel-based systemic therapy in patients with HER2-positive early breast cancer - a multinational phase III study conducted during the COVID-19 pandemic (SABCS 2021)
    Neoadjuvant phase : 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m 2 ) and cyclophosphamide (600 mg/m 2 ) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) and paclitaxel (175 mg/m 2 ) every 3 weeks for 4 cycles. EG12014 has shown equivalent efficacy to Herceptin in regard to clinical response (pCR) and has also demonstrated a similar safety profile. The impact of the COVID-19 pandemic has been comparable between the two treatment arms. The influence of the pandemic on this clinical study has been relatively low considering timing and the participating countries.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • HER-2 overexpression • HER-2 amplification • PGR negative
    |
    Herceptin (trastuzumab) • paclitaxel • cyclophosphamide • epirubicin • Herwenda (trastuzumab biosimilar)
    over4years
    Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=800, Active, not recruiting, EirGenix, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Jan 2022 | Trial primary completion date: Aug 2020 --> Nov 2020
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • Herwenda (trastuzumab biosimilar)
    over4years
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2; N=16; Not yet recruiting; Sponsor: University of Washington
    New P2 trial • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • IGFBP2 (Insulin-like growth factor binding protein 2)
    |
    ER negative • PGR negative
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Hercessi (trastuzumab-strf) • Ogivri (trastuzumab-dkst) • Herwenda (trastuzumab biosimilar)