Population pharmacokinetics, efficacy, and safety of moxetumomab pasudotox in patients with relapsed or refractory hairy cell leukaemia.

ABSTRACT:

Aims

To characterize the pharmacokinetics (PK) of moxetumomab pasudotox, an anti-CD22 recombinant immunotoxin, in adults with relapsed or refractory hairy cell leukaemia, we examined data from a phase 1 study (Study 1001; n = 49) and from the pivotal clinical study (Study 1053; n = 74).

Methods

Data from both studies were pooled (n = 123) to develop a population PK model. Covariates included demographics, disease state, liver and kidney function, prior treatment, and antidrug antibodies (ADAs). Exposure-response and exposure-safety were analysed separately by study. A 1-compartment model with linear elimination from the central compartment and 2 clearance (CL) rates was developed.

Results

Moxetumomab pasudotox was cleared more rapidly after cycle 1, day 1 (CL₁

SUBMITTER: Kuruvilla D 

PROVIDER: S-EPMC7318999 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature