Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tamibarotene · 1 trial · 2 indications
ORR was defined as: AML: number of participants with complete remission (CR), CR with incomplete blood count recovery (CRi), CR with partial hematologic recovery (CRh), partial remission(PR), or morphologic leukemia-free state (MLFS) determined by the investigator per revised International Working Group (IWG) AML criteria. HR-MDS: the number of participants with CR, PR, marrow CR (mCR), or HI determined by the investigator per revised IWG MDS criteria.
TIR was defined as the number of participants who achieved transfusion independence defined as 8 consecutive weeks of red blood cell (RBC) transfusion independence.
A TEAE was any untoward medical occurrence associated with use of a study drug/study participation, whether or not considered related to study drug after first dose. A TEAE was any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the study drug. A serious TEAE resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received study drug or other important medical events. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy | EXPERIMENTAL | Participants with R/R non-APL AML or R/R HR-MDS will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle. |
| Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy | EXPERIMENTAL | Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle. |
| Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine | EXPERIMENTAL | Newly diagnosed, treatment-naive participants with non-APL AML who are unlikely to tolerate standard intensive chemotherapy will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle. |
| LR-MDS: Tamibarotene Monotherapy | EXPERIMENTAL | Participants with transfusion-dependent LR-MDS without the del 5q abnormality who are refractory to erythropoietin (EPO) treatment or unlikely to respond to EPO treatment will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle. |
| R/R non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab | EXPERIMENTAL | Participants with R/R non-APL AML or R/R HR-MDS will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants will also receive daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks. |
| R/R non-APL AML: Tamibarotene and Azacitidine | EXPERIMENTAL | Participants with R/R non-APL AML will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Tamibarotene | DRUG | Administered as oral tablets |
| Azacitidine | DRUG | Administered via intravenous (IV) or subcutaneous (SC) infusion |
| Daratumumab | DRUG | Administered via IV infusion |
Key Inclusion Criteria: 1. Must have: 1. Relapsed and/or refractory non-APL AML that has failed to achieve a complete remission (CR) or partial remission (PR) following standard induction therapy, or has relapsed after any duration of CR or PR i. Must have measurable disease with bone marrow bl...
Tamibarotene is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is being developed by Syros Pharmaceuticals, Inc. and is currently in Phase 2 clinical development. The drug is not yet approved and remains under investigation for this indication.
Tamibarotene is a retinoid that targets the retinoic acid receptor. It is designed to modulate gene expression by binding to this receptor, which is relevant in the context of Acute Myeloid Leukemia. The drug is being studied for its potential to affect cancer cell differentiation and growth.
Tamibarotene is being developed by Syros Pharmaceuticals, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia. Syros Pharmaceuticals is publicly traded under the ticker symbol SYRS.
Tamibarotene is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being evaluated for its potential use in treating Acute Myeloid Leukemia.
Tamibarotene has been studied in a Phase 2 clinical trial with the identifier NCT02807558. This trial was a biomarker-directed study in participants with Acute Myeloid Leukemia or Myelodysplastic Syndrome. The trial enrolled 155 participants and was conducted in the United States and France. It has been completed.
Yes, Tamibarotene is also known as SY-1425. The clinical trial NCT02807558, which evaluated the drug in Acute Myeloid Leukemia and Myelodysplastic Syndrome, used the name SY-1425 in its title. Both names refer to the same investigational drug being developed by Syros Pharmaceuticals.