Population exposure-response analysis of cabozantinib efficacy and safety endpoints in patients with renal cell carcinoma.

ABSTRACT:

Background

In the phase III METEOR trial, tyrosine kinase inhibitor cabozantinib significantly improved progression-free survival (PFS), objective response rate (ORR), and overall survival compared to everolimus in patients with advanced renal cell carcinoma (RCC) who had received prior VEGFR inhibitor therapy. In METEOR, RCC patients started at a daily 60-mg cabozantinib tablet (Cabometyx™) dose but could reduce to 40- or 20-mg to achieve a tolerated exposure.

Objectives and methods

Exposure-response (ER) models were developed to characterize the relationship between cabozantinib at clinically relevant exposures in RCC patients enrolled in METEOR and efficacy (PFS and tumor response) and safety endpoints.

Results

Compared to the average steady-state cabozantinib conc

SUBMITTER: Lacy S 

PROVIDER: S-EPMC5973957 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature