Exposure-response relationship of olaratumab for survival outcomes and safety when combined with doxorubicin in patients with soft tissue sarcoma.

ABSTRACT:

Purpose

Olaratumab is a recombinant human IgG1 monoclonal antibody against PGDFRα. Olaratumab plus doxorubicin improved survivalversus doxorubicin in an open-label, randomised phase 2 soft tissue sarcoma (STS) trial. We characterised the olaratumab exposure-response relationship for progression-free survival (PFS), overall survival (OS), and safety.

Methods

PFS and OS data from the 133 patients enrolled in the phase 2 study were analysed using time-to-event modelling. The effect of olaratumab on PFS/OS was explored using the trough serum concentration after cycle 1 (C_min1) and the average concentration throughout treatment (C_avg). The rate of treatment-emergent adverse events (TEAEs) was compared across olaratumab exposure quartiles.

Results

PFS

SUBMITTER: Jones RL 

PROVIDER: S-EPMC6373189 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature