Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia.

ABSTRACT:

Background

The BELA and BFORE trials compared bosutinib starting doses of 500 mg once daily (QD) and 400 mg QD, respectively, with imatinib in adults with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML). The B1871048 trial evaluated bosutinib 400 mg QD in Japanese patients with newly diagnosed CP-CML.

Aim

This analysis assessed the impact of a lower bosutinib starting dose on key efficacy and safety outcomes.

Materials & methods

A pharmacokinetic model was used to estimate metrics of bosutinib exposure, and logistic regression was used to investigate relationships with efficacy (cumulative major molecular response [MMR] and cumulative complete cytogenetic response [CCyR]) and safety outcomes (eight prespecified adverse events).

Results

Totals of

SUBMITTER: Garrett M 

PROVIDER: S-EPMC10524044 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature