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    DRUG:

    Ziihera (zanidatamab-hrii)

    i
    Other names: ZW25, ZW 25, ZW-25, JZP-598, JZP 598, JZP598
    Company:
    BeOne Medicines, Jazz, Royalty, Zymeworks
    Drug class:
    HER2 inhibitor
    Related drugs:
    11d
    An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Haihua Yuan
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    HER-2 positive • MSI-H/dMMR • BRAF mutation • BRAF wild-type
    |
    Ziihera (zanidatamab-hrii)
    15d
    BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov)
    P3, N=404, Completed, BeOne Medicines | Active, not recruiting --> Completed
    Trial completion
    |
    temozolomide • Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib) • Partruvix (pamiparib) • Ziihera (zanidatamab-hrii) • Avzivi (bevacizumab-tnjn) • ociperlimab (BGB-A1217) • sitravatinib (MGCD516) • BGB-15025 • BGB-A445 • alcestobart (LBL-007) • surzebiclimab (BGB-A425)
    22d
    Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer. (PubMed, N Engl J Med)
    Zanidatamab plus chemotherapy, both with and without tislelizumab, led to longer progression-free survival than trastuzumab plus chemotherapy among patients with HER2-positive advanced gastroesophageal adenocarcinoma. At this interim analysis, overall survival was longer with zanidatamab-tislelizumab-chemotherapy than with trastuzumab-chemotherapy; further analyses are planned to assess zanidatamab-chemotherapy. Diarrhea was a common adverse event. (Funded by Jazz Pharmaceuticals and others; HERIZON-GEA-01 ClinicalTrials.gov number, NCT05152147.).
    Clinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Tevimbra (tislelizumab-jsgr) • Ziihera (zanidatamab-hrii)
    29d
    1479-0012: Beamion BCGC-1: A study to find a suitable dose of zongertinib used alone and in combination with other treatments to test whether it helps people with different types of HER2+ cancer that has spread (2023-509566-38-00)
    P1/2, N=181, Recruiting, Boehringer Ingelheim International GmbH
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • 5-fluorouracil • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii) • Hernexeos (zongertinib)
    1m
    Bispecific Antibodies and Antibody-Drug Conjugates in Advanced Gastric Adenocarcinoma. (PubMed, Cancers (Basel))
    Along with these developments in drug therapy, more therapies directed at CLDN18.2, HER2, MSI, EGFR, HER3 and trophoblast cell-surface antigen 2 (TROP2) are underway. Here we review future areas in advanced GAC, including zanidatamab's potential role in HER2-positive advanced GAC and deciphering the abundance of anti-CLDN18.2, extending beyond investigative therapies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CLDN18 (Claudin 18)
    |
    HER-2 positive
    |
    Ziihera (zanidatamab-hrii)
    1m
    ZANGEA: Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients (clinicaltrials.gov)
    P2, N=80, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • Ziihera (zanidatamab-hrii)
    1m
    MEDOPP0776: PHASE?IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER (The JAZMINE Study) (2025-524613-89-00)
    P1/2, N=129, Not yet recruiting, Medica Scientia Innovation Research S.L.
    New P1/2 trial
    |
    HER-2 positive • HER-2 amplification
    |
    capecitabine • eribulin mesylate • Tukysa (tucatinib) • dexamethasone • Ziihera (zanidatamab-hrii)
    2ms
    HERIZON-BTC-302: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=286, Recruiting, Jazz Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • Ziihera (zanidatamab-hrii)
    2ms
    DiscovHER PAN-206: A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors (clinicaltrials.gov)
    P2, N=125, Recruiting, Jazz Pharmaceuticals | N=50 --> 125
    Enrollment change
    |
    HER-2 overexpression
    |
    Ziihera (zanidatamab-hrii)
    2ms
    EmpowHER 208: A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (clinicaltrials.gov)
    P2, N=125, Recruiting, Jazz Pharmaceuticals
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Ziihera (zanidatamab-hrii)
    2ms
    Real-World Study on the Efficacy and Safety of Zanidatamab in the Treatment of Patients with HER2-Expressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer (ChiCTR2600119329)
    P=N/A, N=30, The First Affiliated Hospital of Xiamen University; The First Affiliated Hospital of Xiamen University
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Ziihera (zanidatamab-hrii)
    2ms
    Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment (clinicaltrials.gov)
    P2, N=38, Recruiting, Emory University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 amplification • RAS mutation • RAS wild-type • HER-2 positive + RAS wild-type
    |
    Ziihera (zanidatamab-hrii)