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Therapy Name	BAY1436032
Synonyms
Therapy Description	BAY1436032 inhibits mutant IDH1, resulting in decreased levels of (R)-2-hydroxyglutarate (R-2HG) and leading to reduced proliferation and increased differentiation of IDH1-mutant tumor cells (PMID: 28232670, PMID: 32733012).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
BAY1436032		BAY-1436032\|BAY 1436032	IDH1 Inhibitor 8	BAY1436032 inhibits mutant IDH1, resulting in decreased levels of (R)-2-hydroxyglutarate (R-2HG) and leading to reduced proliferation and increased differentiation of IDH1-mutant tumor cells (PMID: 28232670, PMID: 32733012).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
IDH1 R132X	acute myeloid leukemia	no benefit	BAY1436032	Phase I	Actionable	In a Phase I trial, treatment with BAY1436032 in acute myeloid leukemia patients harboring an IDH1 R132X mutation demonstrated safety and resulted in an overall response rate of 15% (4/27), including one complete remission, one partial remission, and morphologic leukemia-free state in two patients, stable disease in 67% (18/27), and a median overall survival of 6.6 months, however, due to low response rates for all doses, further clinical development was not supported (PMID: 32733012; NCT03127735).	32733012
IDH1 R132C	acute myeloid leukemia	sensitive	BAY1436032	Preclinical - Pdx & cell culture	Actionable	In a preclinical study, BAY1436032 decreased R-2HG levels and inhibited growth of primary acute myeloid leukemia (AML) cells harboring IDH1 R132C in culture, and decreased blast number and increased survival of two AML patient-derived xenograft (PDX) models, one which harbored additional alterations in FLT3, NPM1, and NRAS and one which harbored a KMT2A (MLL) alteration (PMID: 28232670).	28232670
IDH1 R132G	acute myeloid leukemia	sensitive	BAY1436032	Preclinical - Patient cell culture	Actionable	In a preclinical study, BAY1436032 decreased (R)-2-hydroxyglutarate (R-2HG) levels and increased differentiation of patient-derived acute myeloid leukemia cells harboring IDH1 R132G in culture (PMID: 28232670).	28232670
IDH1 R132H	acute myeloid leukemia	sensitive	BAY1436032	Preclinical - Patient cell culture	Actionable	In a preclinical study, BAY1436032 decreased (R)-2-hydroxyglutarate (R-2HG) levels, and inhibited growth and increased differentiation of patient-derived acute myeloid leukemia cells harboring IDH1 R132H in culture (PMID: 28232670).	28232670
IDH1 R132L	acute myeloid leukemia	sensitive	BAY1436032	Preclinical - Patient cell culture	Actionable	In a preclinical study, BAY1436032 decreased (R)-2-hydroxyglutarate (R-2HG) levels, and inhibited growth and increased differentiation of patient-derived acute myeloid leukemia cells harboring IDH1 R132L in culture (PMID: 28232670).	28232670
IDH1 R132S	acute myeloid leukemia	sensitive	BAY1436032	Preclinical - Patient cell culture	Actionable	In a preclinical study, BAY1436032 decreased (R)-2-hydroxyglutarate (R-2HG) levels, and inhibited growth and increased differentiation of patient-derived acute myeloid leukemia cells harboring IDH1 R132S in culture (PMID: 28232670).	28232670
IDH1 R132H IDH1 H315D	leukemia	predicted - resistant	BAY1436032	Preclinical - Biochemical	Actionable	In a preclinical study, BAY1436032 did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and H315D in culture (PMID: 36222845).	36222845
IDH1 R132H IDH1 T313I	leukemia	predicted - resistant	BAY1436032	Preclinical - Biochemical	Actionable	In a preclinical study, BAY1436032 did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and T313I in culture (PMID: 36222845).	36222845

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02746081	Phase I	BAY1436032	Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors	Completed	USA \| DNK \| DEU	1
NCT03127735	Phase I	BAY1436032	BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)	Completed	USA \| DEU	0

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