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Therapy Name	DS-1001b
Synonyms
Therapy Description	DS-1001b specifically targets IDH1 mutations, including at amino acid R132, which results in decreased 2HG production and potentially leads to increased differentiation and decreased proliferation of IDH1 mutant cancer cells (PMID: 31727689, PMID: 31406254).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
DS-1001b		DS-1001\|DS1001\|Safusidenib\|AB-218\|AB218\|AB 218	IDH1 Inhibitor 8	DS-1001b specifically targets IDH1 mutations, including at amino acid R132, which results in decreased 2HG production and potentially leads to increased differentiation and decreased proliferation of IDH1 mutant cancer cells (PMID: 31727689, PMID: 31406254).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
IDH1 R132H	glioblastoma	sensitive	DS-1001b	Preclinical - Pdx	Actionable	In a preclinical study, treatment with DS-1001b inhibited subcutaneous and intracranial tumor growth in a patient-derived xenograft (PDX) model of glioblastoma harboring IDH1 R132H, and also demonstrated reduced levels of the oncometabolite 2-hydroxyglutarate (2-HG) within tumors and plasma and increased expression of the astrocyte differentiation marker glial fibrillary acidic protein in tumor cells (PMID: 31727689).	31727689
IDH1 R132C	Advanced Solid Tumor	predicted - sensitive	DS-1001b	Preclinical - Biochemical	Actionable	In a preclinical study, DS-1001b inhibited IDH1 R132C enzymatic activity in an in vitro assay, and inhibited production of the oncometabolite 2-hydroxyglutarate (2-HG) in transformed human cells expressing IDH1 R132C in culture (PMID: 31727689).	31727689
IDH1 R132G	Advanced Solid Tumor	predicted - sensitive	DS-1001b	Preclinical - Biochemical	Actionable	In a preclinical study, transformed human cells expressing IDH1 R132G demonstrated sensitivity to DS-1001b in culture, resulting in reduced production of the oncometabolite 2-hydroxyglutarate (2-HG) (PMID: 31727689).	31727689
IDH1 R132H	Advanced Solid Tumor	predicted - sensitive	DS-1001b	Preclinical - Biochemical	Actionable	In a preclinical study, DS-1001b inhibited IDH1 R132H enzymatic activity in an in vitro assay, and inhibited production of the oncometabolite 2-hydroxyglutarate (2-HG) in transformed human cells expressing IDH1 R132H in culture (PMID: 31727689).	31727689
IDH1 R132L	Advanced Solid Tumor	predicted - sensitive	DS-1001b	Preclinical - Biochemical	Actionable	In a preclinical study, transformed human cells expressing IDH1 R132L demonstrated sensitivity to DS-1001b in culture, resulting in reduced production of the oncometabolite 2-hydroxyglutarate (2-HG) (PMID: 31727689).	31727689
IDH1 R132S	Advanced Solid Tumor	predicted - sensitive	DS-1001b	Preclinical - Biochemical	Actionable	In a preclinical study, transformed human cells expressing IDH1 R132S demonstrated sensitivity to DS-1001b in culture, resulting in reduced production of the oncometabolite 2-hydroxyglutarate (2-HG) (PMID: 31727689).	31727689

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT05303519	Phase II	DS-1001b	Safusidenib Phase 2 Study in IDH1 Mutant Glioma	Active, not recruiting	USA	0
NCT05577416	Phase I	DS-1001b	A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma (AB-218-IIT-201)	Recruiting	AUS	0

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