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Therapy Name	Siremadlin
Synonyms
Therapy Description	Siremadlin (HDM201) binds to MDM2 and inhibits its interaction with p53, which prevents p53 degradation and potentially leads to restoration of p53 signaling and increased tumor cell death (PMID: 30899200, PMID: 27542305).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Siremadlin		HDM201\|HDM-201\|NVP-HDM201	MDM2 Inhibitor 23	Siremadlin (HDM201) binds to MDM2 and inhibits its interaction with p53, which prevents p53 degradation and potentially leads to restoration of p53 signaling and increased tumor cell death (PMID: 30899200, PMID: 27542305).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
TP53 wild-type	Advanced Solid Tumor	predicted - sensitive	Siremadlin	Phase I	Actionable	In a Phase I trial, Siremadlin (HDM201) treatment demonstrated safety and resulted in an overall response rate (ORR) of 3.5% (4/115; all partial responses) and disease control rate (DCR) of 36.5% in patients with TP53 wild-type advanced solid tumors, and at the recommended dose for expansion (120 mg), resulted in an ORR of 10.5% (3/29) and DCR of 44.8% in all patients, and a DCR of 83.3% (10/12) in patients with liposarcoma (PMID: 34862243; NCT02143635).	34862243
TP53 wild-type	acute myeloid leukemia	predicted - sensitive	Siremadlin	Phase I	Actionable	In a Phase I trial, Siremadlin (HDM201) treatment demonstrated safety and resulted in overall response rates of 4.2% (1/24), 20% (3/15), and 22.2% (6/27) for the recommended expansion doses of 120 mg, 250 mg, and 45 mg, respectively, in patients with TP53 wild-type acute myeloid leukemia (PMID: 34862243; NCT02143635).	34862243
TP53 wild-type	Advanced Solid Tumor	predicted - sensitive	Siremadlin	Preclinical - Cell line xenograft	Actionable	In a preclinical study, HDM201 treatment resulted in tumor regression in various cell line xenograft models of Tp53 wild-type tumors (Cancer Res 2016;76(14 Suppl):Abstract nr 4855).	detail...

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02143635	Phase I	Siremadlin	Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt	Completed	USA \| NLD \| FRA \| ESP \| DEU	3
NCT02780128	Phase I	Siremadlin Ceritinib + Ribociclib Trametinib	Next Generation Personalized Neuroblastoma Therapy	Terminated	USA	0
NCT05447663	Phase Ib/II	Siremadlin	A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant	Terminated	ITA \| ESP \| DEU	0

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