Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ivosidenib, Ivosidenib Oral Tablet, Ivosidenib 500mg, Ivosidenib 500mg Oral Tablet
Ivosidenib+ azacitidine · 1 trial · 1 indication
relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib
| Arm | Type | Description |
|---|---|---|
| ivosidenib + Oral azacitidine | EXPERIMENTAL | cf intervention |
| Name | Type | Description |
|---|---|---|
| Ivosidenib + oral azacitidine | DRUG | Subjects will be administered treatment over 28-day cycles until progression or another reason (unacceptable toxicity, patient choice to discontinue study treatment, sponsor decision, HSCT at any time, patients who require the use of any of the excluded therapies). The treatment is the association of ivosidenib with oral azacitidine. * The investigational medicinal product is ivosidenib. Two tablets (500 mg) will be administered as a single dose, once daily, during 28 days-cycles until discontinuation. * The auxiliary treatment is oral azacitidine. Oral AZA 300 mg will be given once-daily for 14 days of repeated 28-day treatment cycles. For all patients, oral AZA will be interrupted systematically after day 14 of each 28-days cycle. |
Inclusion Criteria: 1. Male or female ≥ 55 years of age at the time of signing informed consent 2. Patients with confirmation of newly diagnosed AML by 2022 WHO criteria 3. Presence of IDH1 R132 mutation at AML diagnosis 4. Achievement CR or CRi following induction therapy by intensive chemotherapy...
Ivosidenib is an investigational small molecule being studied for acute myeloid leukemia, cholangiocarcinoma, clonal cytopenia of undetermined significance, IDH1-mutated malignancies, and locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation. It is also being evaluated in combination with oral azacitidine for AML patients in complete remission after intensive chemotherapy.
Ivosidenib targets IDH1 mutations. It is a kinase inhibitor, belonging to the -nib class of drugs. The drug is being studied in biomarker-selected patient populations with IDH1-mutated cancers, including acute myeloid leukemia, cholangiocarcinoma, and chondrosarcoma.
Ivosidenib is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting clinical trials of the drug across multiple oncology indications, including a Phase 3 study in chondrosarcoma and Phase 2 studies in other IDH1-mutated malignancies.
Ivosidenib is in Phase 3 clinical development for locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation. It is also being studied in Phase 2 trials for clonal cytopenia of undetermined significance, cholangiocarcinoma, and acute myeloid leukemia. The drug remains investigational and is not yet approved.
Ivosidenib is being studied in four clinical trials. NCT06127407 is a Phase 3 trial in chondrosarcoma. NCT05030441 is a Phase 2 trial in clonal cytopenia of undetermined significance. NCT06081829 is a Phase 2 trial in cholangiocarcinoma. NCT07463768 is a Phase 2 trial combining ivosidenib with oral azacitidine in AML.
Ivosidenib is the single-agent drug, while Ivosidenib plus oral azacitidine refers to a combination regimen being studied in acute myeloid leukemia. The combination is being evaluated in a Phase 2 trial for patients over 55 with an IDH1 mutation who are in complete remission after intensive chemotherapy.