Pharmacokinetic (PK) assessment of revumenib in patients with relapsed/refractory (R/R) acute leukemias harboring a KMT2A rearrangement ( KMT2A r) or NPM1 mutation ( NPM1 m): Impact of food and concomitant medications.

6528 Background: Revumenib is a first-in-class, oral, potent, and selective inhibitor of the menin-KMT2A interaction that disrupts multiple drivers of leukemogenesis such as KMT2A rearrangements ( KMT2A r) and NPM1 mutations ( NPM1 m). Revumenib is approved in the United States in patients 1 year and older for the treatment of R/R acute leukemia with a KMT2A translocation or R/R acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Given the severity of disease, frequent polypharmacy, and variable clinical status in this population, dosing flexibility is essential to support consistent treatment delivery and optimize outcomes. This analysis characterizes the PK of revumenib and its major metabolite (M1), with emphasis on factors that may influence dosing flexibility, including food and concomitant medications such as CYP3A4 inhibitors (CYP3A4i) and gastric acid–reducing agents such as antacids, H2 blockers (H2Bs), and proton pump inhibitors (PPIs). Methods: PK data were obtained from 286 adult (≥18 years) and 49 pediatric (