Population Pharmacokinetic and Exposure-Response Analyses of Ibrutinib Combined With Bendamustine and Rituximab in Patients With Mantle Cell Lymphoma.

ABSTRACT: Efficacy and safety of ibrutinib 560 mg once daily or placebo combined with bendamustine and rituximab (BR) were assessed in patients with mantle cell lymphoma in a randomized phase 3 study (SHINE). The analysis described explores the ibrutinib population pharmacokinetics (PK) and exposure-response (E-R) relationships of selected efficacy and safety endpoints. Ibrutinib PK was consistent with previous assessments, characterized by an open two-compartment disposition model with sequential zero-first order oral absorption after a lag time. Ibrutinib treatment was efficacious in extending PFS versus placebo (HR: 0.75; 95% CI: 0.59 to 0.96), although similar OS, CRR, and ORR were observed. PFS benefit was similar across the quartiles of ibrutinib exposure, suggesting that systemic exposures ob

SUBMITTER: Gisleskog PO 

PROVIDER: S-EPMC12521056 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature