Therapy Detail
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| Therapy Name | LY3410738 |
| Synonyms | |
| Therapy Description |
LY3410738 is a covalent inhibitor of mutant IDH1, which may lead to anti-tumor activity in IDH1-mutant tumors (PMID: 36056177). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| LY3410738 | LY-3410738|LY 3410738 | IDH1 Inhibitor 8 | LY3410738 is a covalent inhibitor of mutant IDH1, which may lead to anti-tumor activity in IDH1-mutant tumors (PMID: 36056177). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| IDH2 R172X | acute myeloid leukemia | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 demonstrated safety and inhibited D-2-HG in patients with relapsed or refractory IDH-mutant acute myeloid leukemia, resulting in a composite complete remission (CRc) rate of 46% (6/13, 4 CR, 1 CRh, 1 CRi/CRp) in IDH inhibitor-naive patients harbor IDH2 R172 mutations (Cancer Res (2023) 83 (8_Supplement): CT026; NCT04603001). | detail... |
| IDH1 R132H IDH1 D279N | acute myeloid leukemia | sensitive | LY3410738 | Preclinical - Cell culture | Actionable | In a preclinical study, LY3410738 inhibited (R)-2-hydroxyglutarate (R-2HG) production and cytokine-independent growth in an acute myeloid leukemia cell line expressing IDH1 R132H and D279N in culture (PMID: 36056177). | 36056177 |
| IDH2 R140X | acute myeloid leukemia | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 demonstrated safety and inhibited D-2-HG in patients with relapsed or refractory IDH-mutant acute myeloid leukemia, resulting in a composite complete remission (CRc) rate of 9% (2/23, 2 CR) in IDH inhibitor-naive patients harbor IDH2 R140 mutations (Cancer Res (2023) 83 (8_Supplement): CT026; NCT04603001). | detail... |
| IDH1 act mut | cholangiocarcinoma | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 treatment demonstrated safety and resulted in D-2-HG inhibition in patients with IDH-mutant advanced solid tumors, and led to partial response in 1 and stable disease in 22 of 42 patients with relapsed or refractory cholangiocarcinoma and partial response in 3 and stable disease in 9 of 22 patients with glioma (Cancer Res (2023) 83 (8_Supplement): CT098; NCT04521686). | detail... |
| IDH1 mutant | acute myeloid leukemia | predicted - sensitive | LY3410738 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, LY3410738 reversed mutant IDH1-induced differentiation block in patient-derived acute myeloid leukemia (AML) cells, inhibited 2-HG production, induced differentiation, and eliminated AML cells in patient-derived orthotopic animal models of IDH1-mutant AML (AACR 2019 Annual Meeting, Abstract LB-274). | detail... |
| IDH1 act mut | brain glioma | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 treatment demonstrated safety and resulted in D-2-HG inhibition in patients with IDH-mutant advanced solid tumors, and led to partial response in 1 and stable disease in 22 of 42 patients with relapsed or refractory cholangiocarcinoma and partial response in 3 and stable disease in 9 of 22 patients with glioma (Cancer Res (2023) 83 (8_Supplement): CT098; NCT04521686). | detail... |
| IDH2 act mut | brain glioma | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 treatment demonstrated safety and resulted in D-2-HG inhibition in patients with IDH-mutant advanced solid tumors, and led to partial response in 1 and stable disease in 22 of 42 patients with relapsed or refractory cholangiocarcinoma and partial response in 3 and stable disease in 9 of 22 patients with glioma (Cancer Res (2023) 83 (8_Supplement): CT098; NCT04521686). | detail... |
| IDH1 R132X | acute myeloid leukemia | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 demonstrated safety and inhibited D-2-HG in patients with relapsed or refractory IDH-mutant acute myeloid leukemia, resulting in a composite complete remission (CRc) rate of 38% (12/32, 5 CR, 2 CRh, 5 CRi/CRp) in IDH inhibitor-naive patients harbor IDH1 R132 mutations (Cancer Res (2023) 83 (8_Supplement): CT026; NCT04603001). | detail... |
| IDH2 act mut | cholangiocarcinoma | predicted - sensitive | LY3410738 | Phase I | Actionable | In a Phase I trial, LY3410738 treatment demonstrated safety and resulted in D-2-HG inhibition in patients with IDH-mutant advanced solid tumors, and led to partial response in 1 and stable disease in 22 of 42 patients with relapsed or refractory cholangiocarcinoma and partial response in 3 and stable disease in 9 of 22 patients with glioma (Cancer Res (2023) 83 (8_Supplement): CT098; NCT04521686). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04521686 | Phase I | LY3410738 | Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations | Active, not recruiting | USA | FRA | ESP | AUS | 5 |
| NCT04603001 | Phase I | LY3410738 | Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations | Active, not recruiting | USA | ISR | FRA | FIN | ESP | DEU | CAN | BEL | AUS | 3 |
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