Therapy Detail
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| Therapy Name | Azacitidine + Ivosidenib |
| Synonyms | |
| Therapy Description | |
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| 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). |
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| 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... |
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| 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 |
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