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Association details:
| Biomarker: | MDM2 amplification |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | brigimadlin (BI 907828) (MDM2-p53 antagonist) |
| Direction: | Sensitive |
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:
More C2 evidence
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:
Less C2 evidence
Source:
Title:
Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.
Published date:
01/17/2023
Excerpt:
In the monotherapy trial, the responding patients had iCC (80 mg q3w; MDM2-amplified; 73% tumor shrinkage; PFS event at 404 days) and ampullary adenocarcinoma (45 mg q3w; MDM2-amplified; 51% tumor shrinkage; ongoing, PFS censored at 255 days). In the combination trial, all 3 responding patients had MDM2-amplified biliary tract adenocarcinoma (2 iCC, 1 GBC); tumor shrinkage was 49–54%; PFS was 162–241 days....The MDM2–p53 antagonist BI 907828 has shown a manageable safety profile and encouraging preliminary efficacy in patients with BTC, with 5 PRs and 2 SD in 8 patients.
DOI:
10.1200/JCO.2023.41.3_suppl.543
Trial ID:
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:
A 51-year-old male with MDM2-amplified cholangiocarcinoma. Following 3 prior lines of therapy, he received brigimadlin 80 mg q3w, which was reduced to 45 mg q3w for 38 days in cycle 2 due to grade 4 thrombocytopenia and grade 4 neutropenia. The patient achieved a partial response by day 22, which was still evident on day 360; maximum tumor shrinkage was −73%.
DOI:
10.1158/2159-8290.CD-23-0153
