Population Pharmacokinetics of Valemetostat and Exposure-Response Analyses of Efficacy and Safety in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma.

ABSTRACT: Valemetostat is a dual inhibitor of EZH2/1 approved in Japan for the treatment of relapsed/refractory (R/R) adult T-cell lymphoma/leukemia (ATLL) and R/R peripheral T-cell lymphoma (PTCL). It is administered orally once daily (QD) at 200 mg. Here, we present comprehensive population pharmacokinetic (PPK) and exposure-response (ER) analyses of valemetostat. The PPK model included data from six clinical trials in patients with non-Hodgkin lymphoma, including ATLL/PTCL, or healthy participants. ER efficacy analyses were based on data from one phase 2 clinical trial in patients with PTCL; ER safety analyses used data from three trials in patients with ATLL or PTCL. Valemetostat unbound average concentration up to event was used as the exposure metric. ER analyses included overall response rate

SUBMITTER: Inoue H 

PROVIDER: S-EPMC12649291 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature