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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 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 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 |
| 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 act mut | oligodendroglioma | sensitive | Vorasidenib | Guideline | Actionable | Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 1p19q codeleted oligodendroglioma 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 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... |
| 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 act mut | oligodendroglioma | sensitive | Vorasidenib | Guideline | Actionable | Voranigo (vorasidenib) is included in guidelines as adjuvant therapy for patients with WHO grade 2 1p19q codeleted oligodendroglioma harboring an IDH1 activating mutation (NCCN.org). | detail... |
| 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 |
| 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 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... |
| 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 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 |
| 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... |
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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 |
| 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 |
| NCT03343197 | Phase I | Ivosidenib Vorasidenib | Study of AG-120 and AG-881 in Subjects With Low Grade Glioma | Active, not recruiting | USA | 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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