Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enasidenib mesylat dose escalation · 1 trial · 3 indications
Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
| Arm | Type | Description |
|---|---|---|
| Enasidenib mesylat | EXPERIMENTAL | Participants will self administer the enasidenib orally everyday. |
| Name | Type | Description |
|---|---|---|
| Enasidenib mesylat dose escalation | DRUG | Subjects will participate dose escalation with a starting dose of 100 mg. Enasidenib will be self administered orally and daily. |
Inclusion Criteria: 1. Documented diagnosis of * MDS according to WHO/FAB classification that meets IRSS-R classification of low or intermediate risk disease; and a diagnosed as denovo or secondary MDS (MDS-RS eligible if refractory to or declined luspatercept therapy) OR * Dysplastic (nonpr...
Top 20 of 63 competitors
Enasidenib mesylat dose escalation is an investigational small molecule being studied for the treatment of leukemia, specifically in patients with myelodysplastic syndromes and non-proliferative chronic myelomonocytic leukemia without an IDH2 mutation. It is in Phase 1 clinical development and is not yet approved.
Enasidenib mesylat dose escalation is being studied in patients without an IDH2 mutation, and the trial is biomarker-selected. The specific molecular target of this drug is not disclosed in the available information.
Enasidenib mesylat dose escalation is developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY.
Enasidenib mesylat dose escalation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Enasidenib mesylat dose escalation was studied in a completed Phase 1 trial with the identifier NCT05282459. The trial enrolled 17 participants in the United States and evaluated the drug in leukemia, including myeloid and monocytic leukemia.
Enasidenib mesylat dose escalation is a formulation of enasidenib, an IDH2 inhibitor, but it is being studied specifically in patients without an IDH2 mutation. The trial name indicates it is a dose escalation study of enasidenib mesylate.