Core Insights - Salarius Pharmaceuticals announced promising clinical data for seclidemstat in treating higher-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who previously failed or relapsed after hypomethylating agent therapy, with a reported 43% overall response rate [1][6][8] Clinical Study Details - The Phase 1/2 dose-escalation study aims to evaluate the safety, tolerability, maximum tolerated dose, and overall response of seclidemstat in combination with azacitidine in adult patients with higher-risk MDS or CMML [2] - As of May 2024, 16 patients were enrolled in the study, with 14 patients evaluable for efficacy [2] - The study reported a median overall survival of 18.5 months and a median event-free survival of 7.2 months [5][6] Efficacy and Safety Results - Among the 14 evaluable patients, 6 (43%) had an objective response, including 1 complete response and 3 marrow complete responses [6] - Adverse events observed were deemed manageable, with dose-limiting toxicity noted in 1 patient in the 750mg BID cohort [3][6] Future Directions - The study will evaluate up to six dose levels of seclidemstat, with the maximum tolerated dose yet to be reached [7] - Salarius is encouraged by the early results and continues to support its clinical programs while exploring strategic alternatives to maximize shareholder value [8][9]
Clinical Data on Salarius Pharmaceuticals' Seclidemstat in Patients with MDS and CMML Presented at the 2024 European Hematology Association Annual Meeting