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Association details:
| Biomarker: | MDM2 amplification |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | brigimadlin (BI 907828) (MDM2-p53 antagonist) |
| Direction: | Sensitive |
Evidence:
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:
Source:
Title:
A study to test whether BI 907828 helps people with cancer in the biliary tract or pancreas Un estudio para evaluar si BI 907828 ayuda a las personas con cáncer en las vías biliares o el páncreas
Excerpt:
...Written pathology report / molecular profiling report indicating MDM2 amplification (copy number ≥8) and TP53 wild-type status.3. ...
Trial ID:
More C2 evidence
Source:
Title:
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
Excerpt:
...- Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides) must be provided for retrospective confirmation of MDM2 amplification and TP53 status....
Trial ID:
Source:
Title:
This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
Excerpt:
...- Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry....
Trial ID:
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:
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:
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:
In summary, brigimadlin showed a manageable safety profile and encouraging signs of antitumor activity in patients with advanced/metastatic MDM2-amplified solid tumors...
DOI:
10.1158/2159-8290.CD-23-0153
Trial ID:
Source:
Title:
452O - A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours
Published date:
09/05/2022
Excerpt:
Disease control rate (complete + partial response (PR) + stable disease) was 93%/88% in pts with DDLPS/well-differentiated LPS (WDLPS), respectively. A confirmed PR was achieved in 5 pts (2 DDLPS, 3 WDLPS); 3 pts (2 DDLPS, 1 WDLPS) had an unconfirmed PR. Of the pts enrolled into phase Ia, 5/11 with DDLPS and 4/8 with WDLPS achieved a PFS >10.5 months. For pts with other solid tumours, 2/4 with MDM2-amplified biliary tract cancer and 1 with MDM2-amplified pancreatic adenocarcinoma had a confirmed PR. BI 907828 demonstrated antitumour activity and a manageable safety profile in pts with advanced solid tumours, including LPS. The dose-expansion phase is ongoing.
Trial ID:
