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    DRUG:

    Herzuma (trastuzumab-pkrb)

    i
    Other names: CT-P6, CT-P06
    Company:
    Celltrion, Mundipharma, Nippon Kayaku, Teva
    Drug class:
    HER2 inhibitor
    Related drugs:
    10d
    TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 negative • HER-2 expression
    |
    paclitaxel • fulvestrant • letrozole • Herzuma (trastuzumab-pkrb) • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    22d
    Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, M.D. Anderson Cancer Center
    New P2 trial • Minimal residual disease
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar) • Poherdy (pertuzumab-dpzb)
    2ms
    Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. (PubMed, Breast Cancer Res Treat)
    Trastuzumab CT-P6 combined with pertuzumab and chemotherapy can be used in neoadjuvant treatment for HER2-positive early breast cancer, showing pCR rates comparable to the reference trastuzumab and without evidence of immunogenicity. Exploratory analyses of soluble HER2 and anti-trastuzumab CT-P6 antibodies did not demonstrate a significant association with pCR, although this possibility cannot be excluded. Their assessment contributes to the translational understanding of biosimilar integration into curative regimens.
    Observational data • Journal • HEOR • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Herzuma (trastuzumab-pkrb)
    4ms
    Comparative study of the impact of adjuvant trastuzumab and its biosimilars on cardiac function in HER2-positive early breast cancer patients: a single-center study. (PubMed, Front Oncol)
    This study evaluates the cardiac safety of Herzuma® and Kanjinti® compared with Herceptin® in a single-center cohort. While a higher event rate was observed in the Kanjinti® group, the small sample size limits interpretation. Prospective studies with longer follow-up and larger patient number are warranted to better characterize long-term cardiac outcomes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • Kanjinti (trastuzumab-anns)
    4ms
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, University of Washington | Trial primary completion date: Oct 2025 --> Aug 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    carboplatin • paclitaxel • docetaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    4ms
    HERTHENA-Breast-01: Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 --> Apr 2030 | Trial primary completion date: Sep 2029 --> Apr 2030
    Trial completion date • Trial primary completion date
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    5ms
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, University of Washington | N=16 --> 25
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    carboplatin • paclitaxel • docetaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    7ms
    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, Recruiting, University of Washington | Trial primary completion date: Jun 2025 --> Oct 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    carboplatin • paclitaxel • docetaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    8ms
    Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=109, Completed, National Cancer Center, Korea | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 positive • HER-2 amplification
    |
    Herzuma (trastuzumab-pkrb)
    8ms
    To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, Celltrion | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Herzuma (trastuzumab-pkrb) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    10ms
    To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov)
    P1, N=200, Recruiting, Celltrion | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herzuma (trastuzumab-pkrb) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    10ms
    Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov)
    P1, N=17, Terminated, Mayo Clinic | N=39 --> 17 | Suspended --> Terminated; funding - sponsor filing Chapter 11 bankruptcy
    Enrollment change • Trial termination
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • Aliqopa (copanlisib) • Darzalex (daratumumab) • Herzuma (trastuzumab-pkrb) • carfilzomib • Istodax (romidepsin) • Trazimera (trastuzumab-qyyp) • Truxima (rituximab-abbs) • Beleodaq (belinostat)