Brigimadlin (BI 907828): MDM2-p53 antagonist | DDLPS
Phase 3
Indication: Dedifferentiated liposarcoma (DDLPS)
Anchored in external partnership or acquisition
US FDA Fast Track Designation
New Pioneer Drug Designation (Japan)
Through our ongoing research and in partnership with experts in this field, we intend to expand our knowledge about the role of the MDM2-p53 pathway in cancer development. This pathway is an area of high interest for the scientific community as approximately 5-7% of tumors display MDM2 amplifications, including lung cancer and other malignancies, with an incidence of up to 90% in some types of soft tissue sarcoma (STS). BI 907828, our investigational MDM2-p53 antagonist, is a highly potent, oral, small molecule compound that inhibits the interaction between MDM2 and p53, restoring p53 wild type function.
The U.S. Food and Drug Administration provided Fast Track Designation and it is currently being investigated in our clinical trial called Brightline-1 (Clinicaltrials.gov identifier: NCT05218499).
In addition to the trial in people with DDLPS, we have recently initiated our Brightline-2 trial (Clinicaltrials.gov identifier: NCT05512377) in other cancers such as biliary tract, pancreatic and selected solid tumor cancers.
Patient Value
Patients minimally respond or do not respond at all to standard of care. There is an urgent need for more effective, targeted and less toxic treatment options.