Core Insights - Biomea Fusion, Inc. announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory acute leukemia, highlighting sustained clinical responses and encouraging survival rates in FLT3-mutant AML patients [1][8] Clinical Activity Observed - Among 27 enrolled patients, 9 of 11 efficacy-evaluable FLT3m patients showed bone marrow blast reduction, with 5 achieving over 50% reduction [7] - One FLT3m patient achieved complete remission with incomplete hematologic recovery (CRi) sustained for 6 cycles, while another achieved a morphologic leukemia-free state (MLFS) [7] - Two of four efficacy-evaluable FLT3 wild-type patients achieved durable disease control for at least 120 days [7] Pharmacokinetics/Pharmacodynamics - BMF-500 demonstrated good compartmental penetration, with bone marrow and plasma concentrations being comparable [7] - The median overall survival (mOS) for all treated FLT3m patients was 3.8 months for Arm A and 3.5 months for Arm B, which is an improvement compared to the historical mOS of 2.1 months for similar patients [7] Ongoing Dose Escalation - Dose escalation is ongoing at 200 mg BID for Arm A and 75 mg BID for Arm B, with no dose-limiting toxicities reported [7][13] - The company plans to conclude the internal development of BMF-500 in oncology and is exploring strategic partnerships to advance the program [8] About BMF-500 - BMF-500 is an investigational, orally bioavailable, covalent small molecule inhibitor of FLT3, designed to be highly potent and selective, with encouraging potential demonstrated in preclinical studies [10]

Core 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]