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    Association details:
    Biomarker:HER-2 positive
    Cancer:HER2 Positive Breast Cancer
    Drug:zanidatamab (ZW25) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

    Excerpt:
    ...All patients in both Parts 1 and 2 must have HER2-positive and HR-positive disease....
    Trial ID:
    ZWI-ZW25-202
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2023
    Title:

    Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer

    Published date:
    12/02/2023
    Excerpt:
    Four (36%) had pCR, 3 RCB1 (28%) and 4 RCB2 (36%)….Neoadjuvant zanidatamab demonstrates significant preliminary efficacy, (pCR/RCB-1 64%) with a good safety profile in patients with stage I node negative HER2+ BC.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy (1L) for patients (pts) with advanced HER2-positive breast cancer (BC): Updated results from a phase 1b/2 study.

    Published date:
    05/25/2023
    Excerpt:
    Of the 33 efficacy evaluable (EE) pts, confirmed ORR was 90.9% (95% confidence interval [CI]: 75.7, 98.1)….Zani combined with docetaxel demonstrated promising antitumor activity as 1L therapy for advanced HER2+ BC, with a manageable safety profile.
    DOI:
    10.1200/JCO.2023.41.16_suppl.1044
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO-BC 2023
    Title:

    132P - Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer (BC) (ID 345)

    Published date:
    05/07/2023
    Excerpt:
    Neoadjuvant zanidatamab for 3 months showed significant efficacy, (pCR/RCB-1 64%) w/ acceptable safety profile in pts w/ stage I node neg HER2+ BC. The trial is ongoing and has been modified to increase treatment duration to 5mths (10 cycles).
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2022
    Title:

    Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a phase 1b/2 study

    Published date:
    05/26/2022
    Excerpt:
    Cohort 1 of this ongoing open-label, Phase 1b/2 study (NCT04276493) is evaluating zani in combination with docetaxel as a 1L therapy in adult females with advanced HER2+ breast cancer...Of the 22-efficacy evaluable (EE) pts, confirmed ORR was 86.4% (95% CI: 65.1, 97.1). The 6 months PFS rate was 90.9% (95% CI: 68.3, 97.7). Zani and docetaxel combination demonstrated antitumor activity in 1L therapy for advanced HER2+ breast cancer...
    Secondary therapy:
    docetaxel
    DOI:
    10.1200/JCO.2022.40.16_suppl.1031
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2021
    Title:

    Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study

    Published date:
    09/10/2021
    Excerpt:
    Zani in combination with chemo is well tolerated, with encouraging and durable antitumor activity in heavily pretreated (including prior tras, pert, and T-DM1) pts with HER2-positive BC. These data support further investigation of zani as a novel therapeutic for these pts.
    Secondary therapy:
    Chemotherapy
    Trial ID:
    ZWI-ZW25-101