Copanlisib population pharmacokinetics from phase I-III studies and exposure-response relationships in combination with rituximab.

ABSTRACT: Copanlisib dose selection was established under the maximum tolerated dose paradigm, and no dedicated dose-finding studies have investigated copanlisib dose selection when used in combination with rituximab. In CHRONOS-3, copanlisib plus rituximab demonstrated significantly improved progression-free survival versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (iNHL). We conducted a comprehensive investigation of copanlisib population pharmacokinetics (PopPK) from a pooled analysis of 712 patients across nine copanlisib phase I-III studies and exposure-response (ER) relationships for efficacy and safety from the 1-year follow-up of CHRONOS-3. PopPK analyses examined the impact of demographic, laboratory, and comedication covariates on copanlisib between-pat

SUBMITTER: Morcos PN 

PROVIDER: S-EPMC10681405 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature