Therapy Detail

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Therapy Name Vorasidenib
Synonyms
Therapy Description

Vorasidenib (AG-881) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Vorasidenib AG-881|AG881 IDH Inhibitor (Pan) 3 Vorasidenib (AG-881) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH2 R140Q high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, AG-881 treatment decreased tumor 2HG levels in a glioma cell line xenograft model harboring IDH2 R140Q (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH1 R132H high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, AG-881 treatment decreased brain tumor 2HG levels in an orthotopic glioma cell line xenograft model harboring IDH1 R132H (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH1 act mut malignant astrocytoma sensitive Vorasidenib Guideline Actionable Vorasidenib is included in guidelines as adjuvant therapy for patients with astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Vorasidenib is included in guidelines as adjuvant therapy for patients with oligodendroglioma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 R132C fibrosarcoma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, AG-881 treatment decreased tumor 2HG levels in a fibrosarcoma cell line xenograft model harboring IDH1 R132C (Mol Cancer Ther Jan 1 2018 (17) (1 Supp) B126). detail...
IDH2 R140Q IDH2 E343V leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Vorasidenib (AG-881) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and E343V in culture (PMID: 36222845). 36222845
IDH2 mutant high grade glioma predicted - sensitive Vorasidenib Case Reports/Case Series Actionable In a Phase I trial, Vorasidenib (AG-881) treatment resulted in an objective response in 13.6% (3/21, 1 partial response, 2 minor response) and stable disease in 77.3% (17/21) of patients with recurrent or progressive non-enhancing glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with 60.5% of the patients remained progression-free and alive at 24 months (J Clin Oncol 38: 2020 (suppl; abstr 2504); NCT02481154). detail...
IDH1 mutant oligodendroglioma predicted - sensitive Vorasidenib Phase III Actionable In a Phase III trial, Vorasidenib (AG-881) treatment improved progression-free survival (27.7 months vs 11.1 months, HR=0.39, p=0.000000067) and time to next intervention (not reached vs 17.8 months, HR=0.26, p=000000019) in patients with oligodendroglioma or astrocytoma harboring IDH1/2 mutations compared to placebo (J Clin Oncol 41, 2023 (suppl 17; abstr LBA1); NCT04164901). detail...
IDH1 R132H IDH1 H315D leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Vorasidenib (AG-881) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and H315D in culture (PMID: 36222845). 36222845
IDH1 R132H IDH1 T313I leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Vorasidenib (AG-881) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and T313I in culture (PMID: 36222845). 36222845
IDH2 mutant oligodendroglioma predicted - sensitive Vorasidenib Phase III Actionable In a Phase III trial (INDIGO), Vorasidenib (AG-881) treatment improved progression-free survival (27.7 months vs 11.1 months; HR=0.39, p=0.000000067) and time to next intervention (not reached vs 17.8 months, HR=0.26; p=0.000000019) compared to placebo in patients with oligodendroglioma or astrocytoma harboring IDH1/2 mutations (J Clin Oncol 41, 2023 (suppl 17; abstr LBA1); NCT04164901). detail...
IDH2 act mut malignant astrocytoma sensitive Vorasidenib Guideline Actionable Vorasidenib is included in guidelines as adjuvant therapy for patients with astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH2 mutant malignant astrocytoma predicted - sensitive Vorasidenib Phase III Actionable In a Phase III trial (INDIGO), Vorasidenib (AG-881) treatment improved progression-free survival (27.7 months vs 11.1 months; HR=0.39, p=0.000000067) and time to next intervention (not reached vs 17.8 months; HR=0.26, p=0.000000019) compared to placebo in patients with astrocytoma or oligodendroglioma harboring IDH1/2 mutations (J Clin Oncol 41, 2023 (suppl 17; abstr LBA1); NCT04164901). detail...
IDH1 mutant malignant astrocytoma predicted - sensitive Vorasidenib Phase III Actionable In a Phase III trial (INDIGO), Vorasidenib (AG-881) treatment improved progression-free survival (27.7 months vs 11.1 months; HR=0.39, p=0.000000067) and time to next intervention (not reached vs 17.8 months; HR=0.26, p=0.000000019) compared to placebo in patients with astrocytoma or oligodendroglioma harboring IDH1/2 mutations (J Clin Oncol 41, 2023 (suppl 17; abstr LBA1); NCT04164901). detail...
IDH1 mutant high grade glioma predicted - sensitive Vorasidenib Phase I Actionable In a Phase I trial, Vorasidenib (AG-881) treatment resulted in an objective response in 13.6% (3/21, 1 partial response, 2 minor response) and stable disease in 77.3% (17/21) of patients with recurrent or progressive non-enhancing glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with 60.5% of the patients remained progression-free and alive at 24 months (J Clin Oncol 38: 2020 (suppl; abstr 2504); NCT02481154). detail...
IDH2 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Vorasidenib is included in guidelines as adjuvant therapy for patients with oligodendroglioma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH2 R140Q IDH2 A347T leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Vorasidenib (AG-881) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and A347T in culture (PMID: 36222845). 36222845

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02492737 Phase I Vorasidenib Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation Completed USA | FRA 0
NCT04164901 Phase III Vorasidenib Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN 3
NCT05484622 Phase I Vorasidenib Pembrolizumab + Vorasidenib Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Glioma Recruiting USA 0
NCT03343197 Phase I Ivosidenib Vorasidenib Study of AG-120 and AG-881 in Subjects With Low Grade Glioma Active, not recruiting USA 0
NCT02481154 Phase I Vorasidenib Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation Active, not recruiting USA 0


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