Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma.

ABSTRACT:

Background

Exposure-response analyses were conducted to explore the relationship between selected efficacy and safety endpoints and serum phosphate (PO4) concentrations, a potential biomarker of efficacy and safety, in locally advanced or metastatic urothelial carcinoma patients with FGFR alterations treated with erdafitinib.

Methods

Data from two dosing regimens of erdafitinib in a phase 2 study (NCT02365597), 6 and 8-mg/day with provision for pharmacodynamically guided titration per serum PO4 levels, were analyzed using Cox proportional hazard or logistic regression models. Efficacy endpoints were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Safety endpoints were adverse events typical for FGFR inhibitors.

Results

Exposu

SUBMITTER: Dosne AG 

PROVIDER: S-EPMC8807442 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature