Efficacy and safety analysis of the German expanded access program of osimertinib in patients with advanced, T790M-positive non-small cell lung cancer.

ABSTRACT:

Purpose

Osimertinib, a third-generation irreversible mutant-selective inhibitor of EGFR kinase activity was clinically evaluated in the AURA trials, where it showed high clinical efficacy and a favorable toxicity profile in patients with acquired exon 20-EGFR pT790M mutation. We provide the clinical data of the German expanded access program that further characterizes the efficacy and safety of osimertinib in a heterogeneous patient population outside clinical trials.

Methods

We performed a retrospective data analysis on patients who were included into the German osimertinib EAP.

Results

Of 81 patients enrolled, 51 patients (62.9%) with sufficient case report form data were available for efficacy and safety analysis. Unconfirmed overall response rate was 80.0% with 2

SUBMITTER: Stratmann JA 

PROVIDER: S-EPMC11813429 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature