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    DRUG:

    anbenitamab (KN026)

    i
    Other names: KN026, KN-026, KN 026
    Company:
    Alphamab, CSPC Pharma
    Drug class:
    HER2 inhibitor
    Related drugs:
    4d
    A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer (clinicaltrials.gov)
    P3, N=1800, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • doxorubicin hydrochloride • cyclophosphamide • epirubicin • anbenitamab (KN026)
    1m
    Anbenitamab in previously treated HER2-positive gastric cancer (KC-WISE): pre-specified interim analysis of a randomized, phase III clinical trial. (PubMed, Ann Oncol)
    Compared with chemotherapy alone, anbenitamab plus chemotherapy demonstrated clinically meaningful superior PFS and OS in patients with HER2-positive GC/GEJ adenocarcinoma whose previous therapy containing trastuzumab had failed. These findings warrant confirmation in the final analysis.
    P3 data • P3 data: top line • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • paclitaxel • docetaxel • irinotecan • anbenitamab (KN026)
    2ms
    A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer (clinicaltrials.gov)
    P2/3, N=490, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • 5-fluorouracil • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart)
    3ms
    Spatial molecular analyses reveal key features associated with response to KN026 in advanced HER2-positive breast cancer. (PubMed, Br J Cancer)
    Both HER2 and ESR1 are determinant of KN026 efficacy in advanced HER2-positive breast cancer, implying the potential of KN026 combined with endocrine therapy in HER2- and ER-positive breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK12 (Cyclin dependent kinase 12) • TFAP2A (Transcription Factor AP-2 Alpha)
    |
    HER-2 positive • ER positive • HER-2 negative • HER-2 expression
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • anbenitamab (KN026)
    9ms
    JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov)
    P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2 trial
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart) • anbenitamab repodatecan (JSKN003)
    9ms
    Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=880, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2026 --> Jul 2025
    Enrollment open • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    11ms
    A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer (clinicaltrials.gov)
    P3, N=520, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    11ms
    Safety and Efficacy of KN046 in combination with KN026 in Patients with advanced HER2-positive Breast Cancer: a Phase II Trial. (PubMed, Clin Cancer Res)
    The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    12ms
    Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. (PubMed, Signal Transduct Target Ther)
    In the other HER2-positive solid tumor subgroup (n = 34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.
    P1 data • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    1year
    Efficacy and safety of KN026 and docetaxel for HER2-positive breast cancer: a phase II clinical trial. (PubMed, Cancer Commun (Lond))
    KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    1year
    A Phase III Study of KN026 in Combination With HB1801 as Neoadjuvant Therapy for Early or Locally Advanced HER2-Positive Breast Cancer (clinicaltrials.gov)
    P3, N=520, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P3 trial
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)