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|Therapy Name||Azacitidine + Ivosidenib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Azacitidine||Vidaza||azacytidine|CC-486|5-azacytidine|5-AC|U-18496||DNMT inhibitor (Pan) 5||Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome (FDA.gov).|
|Ivosidenib||Tibsovo||AG-120||IDH1 Inhibitor 8||Tibsovo (ivosidenib) inhibits mutant IDH1, leading to increased differentiation and decreased proliferation in IDH1 positive tumors (PMID: 27245312). Tibsovo (ivosidenib) is FDA approved for adult patients with relapsed or refractory IDH1-mutant (R132C/G/H/L/S) acute myeloid leukemia, and in patients 75 years or older with newly diagnosed IDH1-mutant acute myeloid leukemia (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|IDH1 mutant||acute myeloid leukemia||predicted - sensitive||Azacitidine + Ivosidenib||Phase III||Actionable||In a Phase III trial (AGILE), Tibsovo (ivosidenib) and Vidaza (azacitidine) combination treatment demonstrated favorable safety profile, resulted in an overall response rate of 78.3% (18/23, 14 complete remission) in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations, with an overall survival probability at 12-month of 82% (EMJ Hematol. 2020;8(1):47-49; NCT03173248).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT02677922||Phase Ib/II||Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib||A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)||Active, not recruiting|
|NCT03173248||Phase III||Azacitidine + Ivosidenib Ivosidenib||Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)||Recruiting|