Osimertinib: positive results in overall survival in patients with NSCLC with positive mutation in EGFR treated in the first line

The Phase III FLAURA trial has shown positive results in overall survival (OS) with Tagrisso^® (osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who present with epidermal growth factor receptor (EGFR) activating mutations and not previously treated.

As AstraZeneca has announced, osimertinib has demonstrated a statistically and clinically significant improvement of OS, a secondary objective of the FLAURA Phase III trial, compared to erlotinib or gefitinib considered to date as standard treatment. To this end, the efficacy and safety of osimertinib (80 mg per day) was evaluated against EGFR TKI (erlotinib -150 mg daily orally- or gefitinib -250 mg daily orally-) in patients with NSCLC with mutation in EGFR, locally advanced or metastatic without prior treatment.

The randomized, double-blind, multicenter FLAURA trial, which involved 556 patients from 29 countries, achieved its main objective in July 2017 by demonstrating a statistically and clinically significant improvement of progression-free survival (PFS), increasing the time of life of patients without disease progression or death from any cause. In addition, the safety and tolerability of osimertinib were consistent with the known profile. The SG results of this essay will be presented by AstraZeneca on Saturday, September 28 at the first Presidential session of the ESMO Congress to be held in Barcelona.

Osimertinib

Osimertinib is an irreversible third generation EGFR-TKI, designed to inhibit both EGFR activity sensitizing mutations and those that confer resistance (T790M), with clinical activity against central nervous system metastases. It is approved in 74 countries, such as the USA, Japan and those belonging to the EU, for the treatment of 1st line of metastatic NSCLC with EGFR mutations.

Currently, in Spain it is indicated in monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the epidermal growth factor receptor (EGFR) and for the treatment of adult patients with locally advanced or metastatic NSCLC with positive mutation of the EGFR T790M.