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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).

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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).

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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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02579824 Phase I Milademetan DS-3032b for Relapsed and/or Refractory (RR) Myeloma Terminated USA 0
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
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
NCT05012397 Phase II Milademetan Milademetan in Advanced/Metastatic Solid Tumors Terminated USA 0
NCT02319369 Phase I Milademetan Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-3032b in Hematological Malignancies Terminated USA 0


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