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|Therapy Name||Azacitidine + Ivosidenib + Venetoclax|
|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).|
|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, patients 75 years or older with newly diagnosed IDH1-mutant acute myeloid leukemia, and patients with advanced or metastatic IDH1-mutant cholangiocarcinoma (FDA.gov).|
|Venetoclax||Venclexta||ABT-199|RG7601|GDC-0199|ABT119||BCL2 inhibitor 22||Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|IDH1 mutant||myeloid neoplasm||predicted - sensitive||Azacitidine + Ivosidenib + Venetoclax||Phase Ib/II||Actionable||In a Phase I/II trial, Tibsovo (ivosidenib) in combination with Vidaza (azacitidine) and Venclexta (venetoclax) demonstrated safety and preliminary efficacy in patients with advanced myeloid malignancies harboring IDH1 mutations, resulted in an overall response rate of 100% (8/8) (EMJ Hematol. 2020;8(1):50-53; NCT03471260).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03471260||Phase Ib/II||Azacitidine + Ivosidenib + Venetoclax Ivosidenib + Venetoclax||Ivosidenib and Venetoclax With or Without Azacitidine in Treating Participants With IDH1 Mutated Hematologic Malignancies||Recruiting||USA||0|