Therapy Detail

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Therapy Name Azacitidine + Enasidenib
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|Onureg 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 and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).
Enasidenib Idhifa AG-221 IDH2 Inhibitor 2 Idhifa (enasidenib) inhibits IDH2 to prevent 2HG formation, which may promote differentiation and inhibit proliferation of cancer cells (PMID: 28280273). Idhifa (enasidenib) is FDA-approved for use in patients with relapsed or refractory acute myeloid leukemia harboring an IDH2 mutation (R140Q/L/G/W, R172K/M/G/S/W) (FDA.gov).

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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH2 R172X myelodysplastic syndrome predicted - sensitive Azacitidine + Enasidenib Phase II Actionable In a Phase II trial, Idhifa (enasidenib) and Vidaza (azacitidine) combination treatment was well tolerated and resulted in an overall response rate of 68% (30/46, 11 complete remission (CR), 3 partial remission, 12 marrow CR, 4 hematological improvement only) in patients with higher-risk myelodysplastic syndrome harboring IDH2 R140 or R172 mutations who were naive to hypomethylating agents, with a median overall survival of 21.3 months (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7010-7010; NCT03383575). detail...
IDH2 R140X myelodysplastic syndrome predicted - sensitive Azacitidine + Enasidenib Phase II Actionable In a Phase II trial, Idhifa (enasidenib) and Vidaza (azacitidine) combination treatment was well tolerated and resulted in an overall response rate of 68% (30/46, 11 complete remission (CR), 3 partial remission, 12 marrow CR, 4 hematological improvement only) in patients with higher-risk myelodysplastic syndrome harboring IDH2 R140 or R172 mutations who were naive to hypomethylating agents, with a median overall survival of 21.3 months (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7010-7010; NCT03383575). detail...

Filtering

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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03683433 Phase II Azacitidine + Enasidenib Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation Unknown status USA 0
NCT03013998 Phase Ib/II Azacitidine + Enasidenib Azacitidine + Entospletinib Cytarabine + Daunorubicin + Samalizumab Azacitidine + BI 836858 Study of Biomarker-Based Treatment of Acute Myeloid Leukemia Recruiting USA 0
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) Unknown status USA | CAN 10
NCT03383575 Phase II Azacitidine + Enasidenib Enasidenib Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome Active, not recruiting USA 0


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