^
    Back
    Association details:
    Biomarker:MDM2 amplification
    Cancer:Liposarcoma
    Drug:brigimadlin (BI 907828) (MDM2-p53 antagonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Brightline-1: A study to compare BI 907828 with doxorubicin in people with a type of cancer called dedifferentiated liposarcoma

    Excerpt:
    ...Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or NGS must be available.5. ...
    Trial ID:
    2021-002392-20
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma

    Excerpt:
    ......
    Trial ID:
    Brightline-4
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

    Excerpt:
    ...- Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available....
    Trial ID:
    Brightline-1
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Discov
    Title:

    The MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study

    Published date:
    08/04/2023
    Excerpt:
    We report phase Ia data indicating that the oral MDM2–p53 antagonist brigimadlin has a manageable safety profile and shows encouraging signs of efficacy in patients with solid tumors, particularly those with MDM2-amplified advanced/metastatic well-differentiated or dedifferentiated liposarcoma
    DOI:
    10.1158/2159-8290.CD-23-0153
    Trial ID:
    NCT03449381
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2021
    Title:

    1548P - A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with advanced/metastatic sarcoma

    Published date:
    09/13/2021
    Excerpt:
    Three of 7 pts with well-differentiated LPS achieved a PR (all were MDM2-amplified)...BI 907828 showed a manageable safety profile, favourable PK, and early signs of anti-tumour activity in patients with sarcoma, especially MDM2-amplified well or de-differentiated liposarcomas.
    Trial ID:
    NCT03449381
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors.

    Published date:
    05/19/2021
    Excerpt:
    BI 907828 given on day 1 of 21-day cycles (Arm A) or days 1 and 8 of 28-day cycles (Arm B)….In Arm A, a confirmed PR was seen in 2 pts with MDM2-amplified LPS (one PR lasted > 2 years) and SD in 17 pts.
    DOI:
    10.1200/JCO.2021.39.15_suppl.3016
    Trial ID:
    NCT03449381