Therapy Detail

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Therapy Name Azacitidine + Ivosidenib + Venetoclax
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).
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 (AML) or myelodysplastic syndrome, patients 75 years or older with newly diagnosed IDH1-mutant AML, in combination with Vidaza (azacitidine) for patients with newly-diagnosed IDH1-mutant AML, and patients with advanced or metastatic IDH1-mutant cholangiocarcinoma (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119|Venclyxto BCL2 inhibitor 27 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).

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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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 Ib/II trial, Tibsovo (ivosidenib) in combination with Vidaza (azacitidine) and Venclexta (venetoclax) demonstrated safety and efficacy in patients with IDH1-mutant advanced myeloid malignancies, and led to a CRc (complete response (CR) + CR with partial hematologic recovery + CR with incomplete hematologic recovery) rate of 90% (17/19), 12-mo event-free survival (EFS) rate of 84%, 24-mo overall survival (OS) rate of 75%, and median EFS and OS were not reached (PMID: 37102976; NCT03471260). 37102976

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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 Patients With IDH1 Mutated Hematologic Malignancies Recruiting USA 0
NCT05401097 Phase II Azacitidine + Enasidenib + Venetoclax Azacitidine + Ivosidenib + Venetoclax IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) Recruiting USA 0


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