Therapy Detail
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| Therapy Name | BI 907828 |
| Synonyms | |
| Therapy Description |
BI 907828 is an MDM2 inhibitor that potentially inhibits tumor growth and improves anti-tumor immunity (PMID: 31201607; Cancer Res 2018;78(13 Suppl):Abstract nr 4866). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| BI 907828 | BI907828|BI-907828|Brigimadlin | MDM2 Inhibitor 23 | BI 907828 is an MDM2 inhibitor that potentially inhibits tumor growth and improves anti-tumor immunity (PMID: 31201607; Cancer Res 2018;78(13 Suppl):Abstract nr 4866). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 wild-type | renal cell carcinoma | sensitive | BI 907828 | Preclinical - Cell culture | Actionable | In a preclinical study, BI 907828 inhibited viability of TP53 wild-type renal cell carcinoma cell lines in culture (PMID: 39259562). | 39259562 |
| MDM2 amp | osteosarcoma | sensitive | BI 907828 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, BI 907828 induced tumor regression in a cell line xenograft model of MDM2-amplified osteosarcoma (PMID: 39259562). | 39259562 |
| MDM2 amp TP53 wild-type | intrahepatic cholangiocarcinoma | predicted - sensitive | BI 907828 | Case Reports/Case Series | Actionable | In a Phase Ia/Ib trial, BI 907828 treatment resulted in a partial response in a patient with MDM2-amplified (CN=9), TP53 wild-type metastatic intrahepatic cholangiocarcinoma, with treatment lasting 12 months (PMID: 38567193; NCT03449381). | 38567193 |
| MDM2 amp TP53 wild-type | Advanced Solid Tumor | predicted - sensitive | BI 907828 | Phase I | Actionable | In a Phase I trial, BI 907828 treatment demonstrated safety and efficacy in patients with advanced solid tumors, resulting in a median progression-free survival of 8.1 months and an overall response rate of 11.1% (6/54, all partial responses (PR), 4 well-differentiated liposarcoma, 1 intrahepatic cholangiocarcinoma, 1 pancreatic cancer), with all PRs occurring in patients harboring an MDM2 amplification (PMID: 37269344; NCT03449381). | 37269344 |
| TP53 wild-type | liposarcoma | sensitive | BI 907828 | Preclinical - Cell culture | Actionable | In a preclinical study, BI 907828 inhibited viability of TP53 wild-type liposarcoma cell lines in culture (PMID: 39259562). | 39259562 |
| MDM2 amp TP53 wild-type | malignant fibrous histiocytoma | sensitive | BI 907828 | Preclinical - Pdx | Actionable | In a preclinical study, BI 907828 induced tumor regression in a patient-derived xenograft (PDX) model of MDM2-amplified, TP53 wild-type undifferentiated pleomorphic sarcoma (PMID: 39259562). | 39259562 |
| MDM2 amp TP53 wild-type | glioblastoma | sensitive | BI 907828 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, BI 907828 treatment inhibited viability of a cell line derived from a TP53 wild-type, MDM2-amplified glioblastoma patient-derived xenograft (PDX) model in culture and inhibited tumor cell proliferation, induced apoptosis, and resulted in improved median survival compared to vehicle treatment (10 mg/kg treatment: 218 days and 2 mg/kg treatment: 57 days vs vehicle: 28 days, p<0.0001) in the PDX model, despite limited blood-brain barrier penetration (PMID: 37828724). | 37828724 |
| MDM2 amp TP53 wild-type | dedifferentiated liposarcoma | predicted - sensitive | BI 907828 | Phase I | Actionable | In a Phase I trial, BI 907828 treatment demonstrated activity in patients with TP53 wild-type, MDM2-amplified dedifferentiated liposarcoma, resulting in a disease control rate (DCR) of 75% (9/12, all stable disease) and progression-free survival (PFS) ranging from 1.5 to 22 months, with PFS greater than 10.5 months in 41.6% (5/12) of patients (PMID: 37269344; NCT03449381). | 37269344 |
| MDM2 amp TP53 wild-type | ampulla of Vater adenocarcinoma | predicted - sensitive | BI 907828 | Case Reports/Case Series | Actionable | In a Phase Ia/Ib trial, BI 907828 treatment resulted in a partial response in a patient with MDM2-amplified (CN=15) metastatic ampullary adenocarcinoma, with treatment ongoing at 19.1 months (PMID: 38567193; NCT03449381). | 38567193 |
| TP53 wild-type | melanoma | sensitive | BI 907828 | Preclinical - Cell culture | Actionable | In a preclinical study, BI 907828 inhibited viability of TP53 wild-type melanoma cell lines in culture (PMID: 39259562). | 39259562 |
| MDM2 amp | liposarcoma | predicted - sensitive | BI 907828 | Case Reports/Case Series | Actionable | In a Phase I trial, BI 907828 treatment led to a partial response in 3 of 7 patients with liposarcoma, all responders harbored MDM2 amplification (Ann Oncol 32 (2021): S1294; NCT03449381). | detail... |
| MDM2 amp TP53 wild-type | lung squamous cell carcinoma | sensitive | BI 907828 | Preclinical - Pdx | Actionable | In a preclinical study, BI 907828 induced prolonged tumor stasis and tumor regression in patient-derived xenograft (PDX) models of MDM2-amplified, TP53 wild-type squamous cell lung carcinoma (PMID: 39259562). | 39259562 |
| MDM2 amp | dedifferentiated liposarcoma | predicted - sensitive | BI 907828 | Preclinical - Pdx | Actionable | In a preclinical study, BI 907828 treatment resulted in tumor regression in patient-derived xenograft (PDX) models of dedifferentiated liposarcoma harboring MDM2 amplification (PMID: 31201607). | 31201607 |
| MDM2 amp TP53 wild-type | well-differentiated liposarcoma | predicted - sensitive | BI 907828 | Phase I | Actionable | In a Phase I trial, BI 907828 treatment demonstrated activity in patients with TP53 wild-type, MDM2-amplified well-differentiated liposarcoma, resulting in a disease control rate of 100%, (7/7, 4 partial responses of at least 12 months, 3 stable disease), and a progression-free survival (PFS) of greater than 7.5 months, with a PFS of at least 14 months or more in 5 patients (PMID: 37269344; NCT03449381). | 37269344 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03449381 | Phase I | BI 907828 | This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) | Active, not recruiting | USA | SWE | POL | ISR | ESP | DNK | DEU | CAN | BEL | 2 |
| NCT06058793 | Phase III | BI 907828 | Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma | Active, not recruiting | USA | ITA | GBR | CAN | BRA | BEL | AUS | ARG | 1 |
| NCT05512377 | Phase II | BI 907828 | Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder | Active, not recruiting | USA | GBR | FRA | ESP | DEU | CHE | BEL | AUS | 5 |
| NCT05376800 | Phase I | BI 907828 | A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma | Active, not recruiting | USA | ESP | BEL | 0 |
| NCT05218499 | Phase II | BI 907828 Doxorubicin | Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma | Active, not recruiting | USA | SWE | NOR | NLD | ITA | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUS | 5 |
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