Biomea Fusion released preliminary Phase I data from its COVALENT-103 trial of BMF-500 in relapsed or refractory acute leukemia (AL). The data, presented at the 2025 European Hematology Association Congress, showed promising bone marrow responses and survival rates in patients with FLT3-mutant AL, particularly those previously treated with gilteritinib. The company is currently evaluating BMF-500, a selective covalent FLT3 inhibitor.
This news holds potential significance for patients with FLT3-mutant AL who have limited treatment options after failing gilteritinib and venetoclax. The observed clinical activity, including a complete remission with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and near partial responses, suggests BMF-500 could fill an unmet medical need in this difficult-to-treat patient population. The improved survival rates compared to historical data further underscore the potential benefit.
The COVALENT-103 trial enrolled 27 patients with R/R AL across two arms, exploring BMF-500 with and without a CYP3A4 inhibitor. Of the 18 patients with FLT3 mutations, all had failed gilteritinib. The study reported a median overall survival of 3.5-3.8 months among all FLT3-mutant patients, surpassing the historical median of 2.1 months. Importantly, the drug was generally well-tolerated with no dose-limiting toxicities reported. Dose escalation is ongoing to determine the optimal dose for Phase II trials.
While Biomea plans to conclude its internal development of BMF-500 in oncology, the company is actively seeking strategic partnerships to advance the program. These partnerships will be crucial to accelerating further clinical development and potentially bringing BMF-500 to market as a much-needed therapy for patients with FLT3-mutant R/R AL.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
