Syndax Presents Updated Positive Data from BEAT AML and AUGMENT-102 Phase 1/2 Combination Trials of Revumenib in Patients with Acute Leukemias at EHA 2024 Congress

Core Insights - Revumenib shows promising efficacy in combination with standard therapies for acute myeloid leukemia (AML), with a 96% composite complete remission (CRc) rate in the BEAT AML trial [7][5][6] - The company is advancing revumenib across various acute leukemia patient settings, with plans for a pivotal trial by the end of 2024 [9][6] Company Overview - Syndax Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative cancer therapies, including revumenib, a selective menin inhibitor [3][5] - The company is also developing axatilimab, a monoclonal antibody targeting the CSF-1 receptor [3] Clinical Trial Data - In the BEAT AML trial, 26 newly diagnosed AML patients were enrolled, achieving a 96% CRc rate and 92% minimal residual disease (MRD) negative status [7][8] - The AUGMENT-102 trial reported a 52% CRc rate in patients with relapsed/refractory AML, with a significant portion achieving MRD negative status [5][11] - Revumenib was well-tolerated, with manageable adverse events, and showed no new safety signals when combined with other therapies [8][12] Future Directions - An expansion cohort is ongoing to establish the recommended dose for future trials, with a pivotal trial planned for newly diagnosed patients by year-end 2024 [9][6] - Revumenib has received Orphan Drug Designation and Breakthrough Therapy Designation from the FDA for treating specific AML patient populations [15]