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 |
|---|---|---|---|---|---|---|---|
| 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... |
| 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 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 | 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 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... |
| 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... |
| 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 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... |
| 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 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 |
| 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT05484622 | Phase I | Vorasidenib Pembrolizumab + Vorasidenib | Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Glioma | Recruiting | 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 | GBR | FRA | ESP | DEU | CAN | 3 |
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