Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olutasidenib · 2 trials · 3 indications
Composite complete remission (CRc) rate is defined as patients that meet the criteria for CR + CRh + CRi per the modified European LeukemiaNet (mELN) 2022. * Complete Remission (CR) is defined as absence of leukemia cells in the bone marrow (\< 5% blasts), normal blood counts (absolute neutrophil count ≥ 1000/μL and platelet count ≥ 100,000/μL), and the absence of circulating blasts, and extramedullary disease * Complete Remission with Hematologic recovery (CRh) is defined as meeting all criteria for CR as Bone marrow myeloblasts \< 5%; absence of circulating blasts; absence of extramedullary disease; both ANC ≥ 0.5x109/L (500/µL) and platelet count ≥ 50×109/L (50 000/µL) * Complete Remission with Incomplete hematologic recovery (CRi) is defined as meeting all criteria for Complete Remission (CR) except for either a low neutrophil count (neutropenia) or a low platelet count (thrombocytopenia)
The number of participants experiencing excessive toxicity in six (6) patient safety lead-in over the duration of study treatment will be reported. All treatment-emergent adverse events (TEAEs) will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Composite complete remission (CRc) among participants will be reported as a percentage. CRc is includes number of participants experiencing complete remission \[CR\], complete remission with partial hematologic recovery \[CRh\] or complete remission with incomplete hematologic recovery \[CRi\] after up to 3 cycles as defined by modified 2022 European LeukemiaNet (ELN) criteria.
| Arm | Type | Description |
|---|---|---|
| Olutasidenib and Azacitidine | EXPERIMENTAL | Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission or for whom loss of response is suspected. Subjects with at least a PR after 6 cycles of treatment will continue treatment.. Subjects without at least a PR after 6 cycles of treatment will move to long term follow up. |
| OLUVENAZA Treatment Group | EXPERIMENTAL | Participants in this group will receive combination treatment of Olutasidenib, Venetoclax and Azacitidine orally for up to 12 cycles, each cycle lasting 28 days. Total participation duration is about 14 months |
| Name | Type | Description |
|---|---|---|
| Olutasidenib | DRUG | Olutasidenib 150 mg orally twice a day |
| Azacitidine (AZA) | DRUG | Azacitidine 75 mg/m2 subcutaneously or IV (over 10-40 minutes) |
| Venetoclax | DRUG | Participants will receive Venetoclax as a 100mg tablet to be self-administered orally with a meal and water once daily, two hours after starting Olutasidenib administration, starting on Cycle 1 Day 1. The dosing regimen of Venetoclax is as follows: * Cycle 1: Days 1 - 21 over a 28-day cycle * Cycle 1 Week 1: Ramp-up dosing schedule up to 400mg (4 x 100mg/tablet) * For participants with blast clearance: Cycle 2 and beyond: Days 1 - 14 over a 28-day cycle * For participants with persistent clearance: Cycle 2 through 4: Days 1 - 21 |
| Azacitidine | DRUG | Participants will receive Azacitidine 75 mg/m2 per day via subcutaneous (SC) injection or intravenous (IV) infusion on Days 1-7 of each cycle. |
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of...
Olutasidenib is an investigational small molecule being studied for the treatment of IDH1-mutated cancers, including High Grade Glioma, Acute Myeloid Leukemia, and other IDH1 mutation-positive tumors. It is currently in Phase 2 clinical development for these oncology indications.
Olutasidenib targets the IDH1 enzyme, acting as an inhibitor of this molecular target. By inhibiting mutant IDH1, the drug is designed to address cancers that carry specific IDH1 mutations, such as IDH1 R132 variants, which are found in certain gliomas and leukemias.
Olutasidenib is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with IDH1-mutated cancers.
Olutasidenib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of IDH1-mutated High Grade Glioma and Acute Myeloid Leukemia.
Olutasidenib is being studied in three Phase 2 trials: NCT06161974 evaluates olutasidenib with temozolomide in High Grade Glioma; NCT06782542 studies olutasidenib, venetoclax, and azacitidine in newly diagnosed IDH1-mutated AML; and NCT07471841 examines olutasidenib in relapsed IDH1-mutated AML patients previously treated with venetoclax.
Olutasidenib + TMZ refers to the combination of olutasidenib with temozolomide, a chemotherapy agent, as studied in the NCT06161974 trial for High Grade Glioma. This is not a separate drug but a combination regimen being tested in clinical trials.