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    Association details:
    Biomarker:HER-2 negative
    Cancer:HER2 Negative Breast Cancer
    Drug:balixafortide (POL 6326) (CXCR4 antagonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    GlobeNewswire
    Title:

    Polyphor Ltd: U.S. FDA grants Fast Track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin

    Published date:
    04/19/2018
    Excerpt:
    Polyphor announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326), in combination with eribulin, for the treatment of patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regimens in the metastatic setting.
    Secondary therapy:
    eribulin mesylate
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer

    Excerpt:
    ...- HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)...
    Trial ID:
    NCT01837095
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A clinical study to compare treatment of Balixafortide in combination with Eribulin or Eribulin alone, in patients with no protein HER2 present in their cells and had locally repeated or spread breast cancer.

    Excerpt:
    ...Molecular status and prior therapies:a) Molecular StatusEligible patients are, by their patient records and prior therapy, HER2 negative with any ER or PgR status. ...
    Trial ID:
    2018-004211-42
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    AACR 2021
    Title:

    414 - Efficacy of Balixafortide (POL6326) and Paclitaxel alone and in combination in humanized breast cancer PDX

    Published date:
    03/10/2021
    Excerpt:
    Balixafortide (POL6326) is a potent, selective inhibitor of the chemokine receptor CXCR4 in PhIII for metastatic HER2-negative breast cancer (BC) in combination with tubulin-binding eribulin…The objective response rate for a dose of 5.5mg/kg balixafortide and 1.4mg/m2 eribulin) was 38% (median duration 4.4 months), and the clinical benefit rate was 63% (median duration 8.1 months)...Partial remission was achieved in the combination arm balixafortide+paclitaxel (T/C 13%, 87% inhibition of tumor volume vs vehicle control) which was stat. significantly better than paclitaxel monotherapy (T/C 42%).
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2020
    Title:

    Balixafortide (a CXCR4 antagonist) plus eribulin in HER2 negative metastatic breast cancer: Final analysis from the Phase 1 single arm trial

    Published date:
    11/17/2020
    Excerpt:
    At entry, all 56 women (age range 33−82 years) were HER2 negative, CXCR4 positive. Balixafortide (a CXCR4 antagonist) plus eribulin in HER2 negative metastatic breast cancer...Objective Response Rate (95% CI)...Overall Efficacy Population(N=54)...30% (18−444)...median OS in months (95% CI)...Overall Efficacy Population (N=54)...16.8 (10.6–18.4)...A consistent dose response effect for B + E was suggested across all efficacy endpoints for heavily pretreated pts with HER2 negative MBC.
    Secondary therapy:
    eribulin mesylate