The preliminary analysis as of July 13, 2023, of Dose Level 4 [500 mg once daily (non-CYP3A4 inhibitor arm) and 125 mg once daily (CYP3A4 inhibitor arm), both producing comparable exposures] showed complete responses (CRs) in 2 of 5 AML patients.

Patients were previously treated with standard-of-care and investigational therapies, including allogeneic bone marrow transplants. Both patients who achieved CRs continue on BMF-219 treatment. 

Dose Level 4 is the first dose level to enroll patients with known menin-dependent mutations.

BMF-219 has been generally well tolerated, with no QTc prolongation reported. 

At the time of this analysis, 20 AML patients received BMF-219 during the dose escalation portion of the COVALENT-101 study. 

Dose Level 4 was cleared with no dose-limiting toxicities observed, allowing for the continuation of dose escalation. 

Enrollment for Dose Level 5 has commenced to optimize further and explore the potential to improve upon these preliminary results. Completion of the dose escalation for the acute leukemia cohort is anticipated later this year. 

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