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 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...
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 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 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 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 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 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 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 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 mutant acute myeloid leukemia sensitive Olutasidenib Guideline Actionable Rezlidhia (olutasidenib) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring an IDH1 mutation (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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


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