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brigimadlin

An MDM2-p53 antagonist that promotes p53-mediated cell cycle arrest and apoptosis

brigimadlin: an MDM2-p53 antagonist

Brigimadlin (BI 907828)* is a potent, oral MDM2-p53 antagonist. Brigimadlin binds to MDM2 and blocks the MDM2–p53 interaction; this prevents MDM2 from inactivating p53, thereby restoring p53 function.1,2

Clinical trials (monotherapy and combination therapy): 

  • Brightline-4 is a Phase III trial assessing the safety and efficacy of brigimadlin in patients with advanced dedifferentiated liposarcoma (DDLPS).3
  • Brightline-1 is a Phase II/III trial evaluating brigimadlin vs doxorubicin for the treatment of patients with DDLPS. Recruitment of participants for Brightline-1 has been completed.4 
  • Brightline-2 is a Phase II trial evaluating brigimadlin in patients with biliary tract cancer (BTC) and other solid tumors (pancreatic, urothelial, lung).5 
  • Phase I trials of brigimadlin as monotherapy in patients with TP53 wild-type solid tumors, and in combination with ezabenlimab*, a programmed cell death protein-1 (PD-1) inhibitor, in patients with advanced solid tumors area also underway.6,7 
  • A Phase 0/Ia trial is evaluating brigimadlin in combination with radiation therapy in glioblastoma.8

*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.

Clinical development

Several studies are underway to assess brigimadlin treatment in different cancer types.3-5,8

Brightline-4 is a Phase III open-label, single-arm, multi-center clinical trial. It will assess the safety and efficacy of brigimadlin in patients with treatment-naïve or pre-treated advanced DDLPS.3

Brightline-1 is a Phase II/III trial evaluating brigimadlin vs doxorubicin as first-line treatment in patients with advanced DDLPS.4,9 The primary outcome of the trial is progression-free survival.

Brightline-2 is a Phase II trial evaluating brigimadlin for treatment of patients with locally advanced / metastatic, MDM2 amplified, tp53 wild-type biliary tract adenocarcinoma.5 The trial will also study brigimadlin in pancreatic ductal adenocarcinoma, lung adenocarcinoma, and bladder cancer that are not suitable for targeted treatment and/or standard of care therapy.5,10,11 

A study to determine how brigimadlin is taken up in the tumor and to determine the highest dose of brigimadlin that could be tolerated in combination with radiation therapy in people with a brain tumor called glioblastoma is also ongoing.8,12

brigimadlin clinical trials

Trial numberPhaseCompoundPatient populationStatus

NCT06058793
(Brightline-4, 1403-0019)3

IIIbrigimadlin Advanced dedifferentiated liposarcomaRecruiting 

NCT05218499 (Brightline-1, 1403-0008)4,9

II/III

brigimadlin vs doxorubicin

Advanced dedifferentiated liposarcoma

Completed recruitment

NCT05512377 (Brightline-2, 1403-0011)5,11 

II

brigimadlin monotherapy 

Biliary tract carcinoma and other solid tumors (pancreatic ductal carcinoma, lung adenocarcinoma, bladder cancer)

Recruiting 

NCT03449381 (1403-0001)6,13

I

brigimadlin monotherapy

Advanced solid tumors

Recruiting

NCT03964233 (1403-0002)7

I

brigimadlin + ezabenlimab (PD-1 inhibitor)

Advanced solid tumors

Recruiting

NCT05376800 (1403-0007)8,12 

0/Ia 

brigimadlin monotherapy 

Newly diagnosed glioblastoma

Recruiting 
 

You may also be interested in ...

 

  1. LoRusso P, et al. Cancer Discov. 2023;13:1802-1813.

  2. Schöffski P, et al. Future Oncol. 2023;19:621-629.

  3. ClinicalTrials.gov. NCT06058793. https://clinicaltrials.gov/study/NCT06058793 (Accessed: February 2024).

  4. ClinicalTrials.gov. NCT05218499. https://clinicaltrials.gov/study/NCT05218499 (Accessed: February 2024).

  5. ClinicalTrials.gov. NCT05512377. https://clinicaltrials.gov/study/NCT05512377 (Accessed: February 2024).

  6. ClinicalTrials.gov. NCT03449381. https://clinicaltrials.gov/study/NCT03449381 (Accessed: February 2024).

  7. ClinicalTrials.gov. NCT03964233. https://clinicaltrials.gov/study/NCT03964233 (Accessed: February 2024).

  8. ClinicalTrials.gov. NCT05376800. https://clinicaltrials.gov/study/NCT05376800 (Accessed: February 2024).

  9. Schöffski P, et al. ASCO 2022. Poster TPS11586.

  10. Boehringer Ingelheim. Bringing focus to unmet needs in biliary tract and pancreatic cancers with the Brightline-2 clinical trial. https://www.boehringer-ingelheim.com/human-health/cancer/gastrointestinal-cancers/bringing-focus-biliary-tract-and-pancreatic-cancers (Accessed: February 2024).

  11. Goyal L, et al. ASCO 2023. Poster TPS4179. 

  12. Sarkaria J, et al. ASCO 2023. Poster TPS2081.

  13. Gounder M, et al. ASCO 2022. Abstract 3004.

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