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Association details:
| Biomarker: | MDM2 amplification |
|---|---|
| Cancer: | Liposarcoma |
| Drug: | brigimadlin (BI 907828) (MDM2-p53 antagonist) |
| Direction: | Sensitive |
Evidence:
Source:
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:
Source:
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:
More C2 evidence
Source:
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:
Less C2 evidence
Source:
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:
Source:
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:
Source:
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:
