Therapy Detail
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| Therapy Name | Olutasidenib |
| Synonyms | |
| Therapy Description |
Rezlidhia (olutasidenib) targets IDH1 R132 mutations, leading to decreased 2HG production and potentially promoting differentiation and decreasing proliferation of IDH R132-mutant cancer cells (PMID: 31971798). Rezlidhia (olutasidenib) is FDA approved for use in adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Olutasidenib | Rezlidhia | FT-2102 | IDH1 Inhibitor 8 | Rezlidhia (olutasidenib) targets IDH1 R132 mutations, leading to decreased 2HG production and potentially promoting differentiation and decreasing proliferation of IDH R132-mutant cancer cells (PMID: 31971798). Rezlidhia (olutasidenib) is FDA approved for use in adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| IDH1 R132X | brain glioma | predicted - sensitive | Olutasidenib | Phase Ib/II | Actionable | In a Phase Ib/II trial, Rezlidhia (olutasidenib) treatment was well tolerated and did not meet the primary endpoint, with an objective response rate of 8% (2/25, both partial responses) but led to a disease control rate of 48% (12/25) in patients with glioma harboring IDH1 R132H (n=22), R132L (n=2), R132C (n=1), or R132G (n=1) (PMID: 35639513; NCT04380012). | 35639513 |
| IDH1 mutant | myelodysplastic syndrome | sensitive | Olutasidenib | Guideline | Actionable | Rezlidhia (olutasidenib) is included in guidelines (category 2B) for patients with higher-risk myelodysplastic syndrome harboring an IDH1 mutation (NCCN.org). | detail... |
| IDH1 mutant | acute myeloid leukemia | sensitive | Olutasidenib | Guideline | Actionable | Rezlidhia (olutasidenib) is included in guidelines as systemic therapy for patients with (category 2A) or without (category 2B) relapsed or refractory acute myeloid leukemia harboring an IDH1 mutation (NCCN.org). | detail... |
| IDH1 mutant | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - Has Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 R132H | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132H/C/G/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 act mut | chondrosarcoma | predicted - sensitive | Olutasidenib | Phase Ib/II | Actionable | In a Phase I/II trial, Rezlidhia (olutasidenib) treatment demonstrated acceptable safety and preliminary clinical activity in patients with IDH1-mutant intrahepatic cholangiocarcinoma, and led to stable disease in 31% (4/13) of evaluable patients (J Clin Oncol 38, no. 5_suppl (May 28, 2020); NCT03684811). | detail... |
| IDH1 R132C | acute myeloid leukemia | sensitive | Olutasidenib | Case Reports/Case Series | Actionable | In a clinical case study, Rezlidhia (olutasidenib) treatment resulted in a complete response with treatment ongoing for at least 87 months in a patient with relapsed acute myeloid leukemia harboring IDH1 R132C, along with NPM1 W299Cfs*12 (PMID: 40594997). | 40594997 |
| IDH1 R132C | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 R132S | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132S/C/G/H/L) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 R132G | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132G/C/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 R132L | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132L/C/G/H/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 act mut | intrahepatic cholangiocarcinoma | predicted - sensitive | Olutasidenib | Phase Ib/II | Actionable | In a Phase I/II trial, Rezlidhia (olutasidenib) treatment demonstrated acceptable safety and preliminary clinical activity in patients with IDH1-mutant intrahepatic cholangiocarcinoma, and led to stable disease in 23% (6/23) of the evaluable patients (J Clin Oncol 38, no. 5_suppl (May 28, 2020); NCT03684811). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03684811 | Phase Ib/II | Cisplatin + Gemcitabine + Olutasidenib Azacitidine + Olutasidenib Olutasidenib Nivolumab + Olutasidenib | A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation | Completed | USA | GBR | FRA | ESP | AUS | 1 |
| NCT06668584 | Phase Ib/II | Olutasidenib | A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients with IDH1-mutated Myeloid Malignancies | Recruiting | USA | 0 |
| NCT02719574 | Phase I | Cytarabine + Olutasidenib Olutasidenib Azacitidine + Olutasidenib | Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 1 |
| NCT05564390 | Phase II | Decitabine and Cedazuridine Fludarabine + Melphalan Decitabine and Cedazuridine + Enasidenib Decitabine and Cedazuridine + Olutasidenib Azacitidine + Gilteritinib + Venetoclax Decitabine and Cedazuridine + Venetoclax Cytarabine + Daunorubicin + Gemtuzumab ozogamicin CPX-351 Olutasidenib Decitabine and Cedazuridine + Enasidenib + Venetoclax Cytarabine + Venetoclax Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax Cytarabine + Daunorubicin Cytarabine Azacitidine + Venetoclax Decitabine and Cedazuridine + Olutasidenib + Venetoclax | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | Recruiting | USA | CAN | 1 |
| NCT07130695 | Phase I | Olutasidenib | Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation | Not yet recruiting | USA | 0 |
| NCT06566742 | Phase II | Olutasidenib | A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia. | Recruiting | USA | 0 |
| NCT06543381 | Phase I | Olutasidenib | Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant | Recruiting | USA | 0 |
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