Biomea Fusion(US:BMEA) Globenewswire·2025-05-14 20:05Core Insights - Biomea Fusion, Inc. announced preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500, a covalent FLT3 inhibitor, in adults with acute leukemia, which will be presented at the EHA 2025 Congress [1][2] Group 1: Clinical Trial Overview - The COVALENT-103 study is an open-label Phase I trial evaluating BMF-500 in patients with relapsed or refractory acute leukemia, particularly those with FLT3 mutations who have failed prior therapies [5][15] - As of February 3, 2025, 24 patients were enrolled in the trial, with 4 remaining on treatment, and the study aims to determine the optimal biologic dose and recommended Phase II dose [7][15] Group 2: Efficacy and Safety Results - BMF-500 was well tolerated, with no dose-limiting toxicities or treatment-related discontinuations reported; common treatment-emergent adverse events included febrile neutropenia and nausea [8][13] - Among efficacy-evaluable patients, 81.8% showed clinical activity, with significant reductions in bone marrow blasts observed [8][13] - The median overall survival for the 23 patients enrolled was 3.48 months, while the median overall survival for the efficacy-evaluable FLT3m patients has not yet been reached [8][13] Group 3: Future Directions - Following the completion of the dose escalation phase, Biomea plans to conclude its internal development of BMF-500 in oncology and is actively seeking strategic partnerships to advance the program [14][16]