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Authors | Courtney D. DiNardo, Stephane De Botton, Eytan M. Stein, Gail J. Roboz, Alice S. Mims, Daniel A. Pollyea, Ronan T. Swords, Jessica K. Altman, Robert H. Collins, Gabriel N. Mannis, Geoffrey L. Uy, Will Donnellan, Arnaud Pigneux, Amir T. Fathi, et al. | ||||||||||||
Title | Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study | ||||||||||||
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URL | http://www.bloodjournal.org/content/130/Suppl_1/725 | ||||||||||||
Abstract Text | Blood 2017 130:725 |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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IDH1 R132C | acute myeloid leukemia | sensitive | Ivosidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839). | detail... detail... detail... 29860938 |