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Therapy Detail

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Therapy Name Vorasidenib
Synonyms
Therapy Description

Voranigo (vorasidenib) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674). Voranigo (vorasidenib) is FDA-approved for use in adult and pediatric patients 12 years and older with IDH-mutant grade 2 astrocytoma or oligodendroglioma following surgery (FDA.gov)

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Vorasidenib Voranigo AG-881|AG881 IDH Inhibitor (Pan) 3 Voranigo (vorasidenib) inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784, PMID: 32071674). Voranigo (vorasidenib) is FDA-approved for use in adult and pediatric patients 12 years and older with IDH-mutant grade 2 astrocytoma or oligodendroglioma following surgery (FDA.gov)

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 act mut astrocytoma, IDH-mutant, grade 4 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 4 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 act mut astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH2 act mut astrocytoma, IDH-mutant, grade 3 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 3 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH2 R140Q IDH2 A347T leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and A347T in culture (PMID: 36222845). 36222845
IDH2 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 or 3 1p19q codeleted oligodendroglioma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH1 act mut astrocytoma, IDH-mutant, grade 3 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 3 astrocytoma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH1 R132C fibrosarcoma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) 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...
IDH1 R132H IDH1 T313I leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and T313I in culture (PMID: 36222845). 36222845
IDH2 R172X astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved Actionable In a Phase III trial l (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516
IDH1 R132X astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib FDA approved Actionable In a Phase III trial l (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). detail... 37272516
IDH2 R140Q IDH2 E343V leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH2 R140Q and E343V in culture (PMID: 36222845). 36222845
IDH2 act mut astrocytoma, IDH-mutant, grade 4 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines for patients with recurrent or progressive WHO grade 4 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH1 R132H high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) 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...
IDH2 act mut astrocytoma, IDH-mutant, grade 2 sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 astrocytoma harboring an IDH2 activating mutation (NCCN.org). detail...
IDH2 R140Q high grade glioma predicted - sensitive Vorasidenib Preclinical - Cell line xenograft Actionable In a preclinical study, Voranigo (vorasidenib) 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 mutant low grade glioma predicted - sensitive Vorasidenib Phase I Actionable In a Phase I trial, Voranigo (vorasidenib) treatment resulted in an objective response in 13.6% (3/22, 1 partial response, 2 minor response) and stable disease in 72.7% (16/22) of patients with non-enhancing low-grade glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with a median progression-free survival of 36.8 months, and resulted in stable disease as best response in 56.7% (17/30) of patients with enhancing tumors harboring mutations in IDH1 (n=28) or IDH2 (n=2) (PMID: 34078652; NCT02481154). 34078652
IDH1 R132X oligodendroglioma sensitive Vorasidenib FDA approved Actionable In a Phase III trial l (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH1 R132H/C/G/L/S (PMID: 37272516; NCT04164901). 37272516 detail...
IDH1 R132H IDH1 H315D leukemia predicted - resistant Vorasidenib Preclinical - Biochemical Actionable In a preclinical study, Voranigo (vorasidenib) did not inhibit R-2HG production in a leukemia cell line expressing IDH1 R132H and H315D in culture (PMID: 36222845). 36222845
IDH2 mutant low grade glioma predicted - sensitive Vorasidenib Case Reports/Case Series Actionable In a Phase I trial, Voranigo (vorasidenib) treatment resulted in an objective response in 13.6% (3/22, 1 partial response, 2 minor response) and stable disease in 72.7% (16/22) of patients with non-enhancing low-grade glioma harboring mutations in IDH1 (n=20) or IDH2 (n=1), with a median progression-free survival of 36.8 months, and resulted in stable disease as best response in 56.7% (17/30) of patients with enhancing tumors harboring mutations in IDH1 (n=28) or IDH2 (n=2) (PMID: 34078652; NCT02481154). 34078652
IDH1 act mut oligodendroglioma sensitive Vorasidenib Guideline Actionable Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 or 3 1p19q codeleted oligodendroglioma harboring an IDH1 activating mutation (NCCN.org). detail...
IDH2 R172X oligodendroglioma sensitive Vorasidenib FDA approved Actionable In a Phase III trial l (INDIGO) that supported FDA approval, Voranigo (vorasidenib) treatment significantly improved progression-free survival (27.7 vs 11.1 months, HR 0.39, p<0.001) and time to next intervention (HR 0.26, p<0.001) compared to placebo in adult and pediatric patients 12 years and older with WHO grade 2 oligodendroglioma or astrocytoma harboring susceptible IDH1 or IDH2 mutations, including IDH2 R172K/M/W/S/G (PMID: 37272516; NCT04164901). detail... 37272516

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Completed USA 0
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 | ISR | GBR | FRA | ESP | DEU | CHE | CAN 1


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