Therapy Detail
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| Therapy Name | AG-881 |
| Synonyms | |
| Therapy Description |
AG-881 inhibits both mutant IDH1 and IDH2, thereby inhibiting cell proliferation in tumors expressing mutant IDH (PMID: 27292784). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| AG-881 | AG881|Vorasidenib | 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 R132H | high grade glioma | predicted - sensitive | AG-881 | 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 | high grade glioma | predicted - sensitive | AG-881 | 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 mutant | high grade glioma | predicted - sensitive | AG-881 | 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 R132C | fibrosarcoma | predicted - sensitive | AG-881 | 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 | high grade glioma | predicted - sensitive | AG-881 | 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02492737 | Phase I | AG-881 | Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation | Completed | USA | FRA | 0 |
| NCT02481154 | Phase I | AG-881 | 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 |
| NCT04164901 | Phase III | AG-881 | 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 | ITA | FRA | ESP | DEU | CAN | 4 |
| NCT03343197 | Phase I | Ivosidenib AG-881 | Study of AG-120 and AG-881 in Subjects With Low Grade Glioma | Active, not recruiting | USA | 0 |
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