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Therapy Name | Milademetan |
Synonyms | |
Therapy Description |
Milademetan binds to MDM2 and prevents binding to p53, resulting in activation of p53 signaling and increased tumor cell apoptosis (PMID: 29416773, PMID: 32651541). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Milademetan | DS-3032b|Milademetan Tosylate|DS3032b|DS 3032b|RAIN-32 | MDM2 Inhibitor 23 | Milademetan binds to MDM2 and prevents binding to p53, resulting in activation of p53 signaling and increased tumor cell apoptosis (PMID: 29416773, PMID: 32651541). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
MDM2 amp | neuroendocrine tumor | predicted - sensitive | Milademetan | Case Reports/Case Series | Actionable | In a Phase I trial, Milademetan demonstrated safety and preliminary activity in patients with advanced solid tumors, and resulted in prolonged stable disease in 2 patients with MDM2-amplified tumors, 1 with liposarcoma and 1 with carcinoid tumor (J Clin Oncol 34, 2016 (suppl; abstr 2581; NCT01877382). | detail... |
MDM2 amp TP53 wild-type | heart sarcoma | predicted - sensitive | Milademetan | Phase Ib/II | Actionable | In a Phase Ib/II trial, Milademetan treatment resulted in an overall response rate of 20% (2/10, both partial responses), a disease control rate of 60%, a median progression-free survival of 4.7 months, and a median overall survival of 12.2 months in patients with MDM2-amplified, TP53 wild-type intimal sarcoma (PMID: 37369013). | 37369013 |
MDM2 amp | dedifferentiated liposarcoma | sensitive | Milademetan | Phase I | Actionable | In a Phase I trial, Milademetan treatment resulted in an objective response rate of 3.8% (2/53, 2 partial responses), a disease control rate of 58.5%, and a median progression-free survival of 7.2 months in patients with dedifferentiated liposarcoma, 100% (22/22) of the patients tested for MDM2 had MDM2 amplification (CN > 6) with a median CN of 28.6 (PMID: 36669146; NCT01877382). | 36669146 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04979442 | Phase III | Trabectedin Milademetan | Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (MANTRA) (MANTRA) | Terminated | USA | POL | ITA | IRL | GBR | FRA | ESP | DEU | CAN | BEL | AUT | 4 |
NCT02319369 | Phase I | Milademetan | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-3032b in Hematological Malignancies | Terminated | USA | 0 |
NCT05012397 | Phase II | Milademetan | Milademetan in Advanced/Metastatic Solid Tumors | Terminated | USA | 0 |
NCT01877382 | Phase I | Milademetan | A Phase 1 Multiple Ascending Dose Study of DS-3032b, an Oral Murine Double Minute 2 (MDM2) Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas | Completed | USA | 0 |
NCT02579824 | Phase I | Milademetan | DS-3032b for Relapsed and/or Refractory (RR) Myeloma | Terminated | USA | 0 |