Venetoclax exposure-efficacy and exposure-safety relationships in patients with treatment-naive acute myeloid leukemia who are ineligible for intensive chemotherapy.

ABSTRACT: This study evaluated venetoclax population pharmacokinetics (popPK) in patients with treatment-naïve acute myeloid leukemia and assessed the relationship between venetoclax exposure and clinical response for venetoclax in combination with either a hypomethylating agent (HMA) or low-dose cytarabine (LDAC). A total of 771 patients who received venetoclax from 5 Phase 1-3 studies were included in the popPK model. Exposure-response analyses included data from 575 patients for venetoclax/placebo plus HMA and 279 patients for venetoclax/placebo plus LDAC. The popPK model successfully characterized venetoclax plasma concentrations over time and confirmed venetoclax exposure did not vary significantly with age, weight, sex, mild to moderate hepatic impairment, or mild to severe renal impairment. A

SUBMITTER: Brackman D 

PROVIDER: S-EPMC9303465 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature