Positive Phase III FLAURA study of Tagrisso as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor mutation-positive NSCLC. -AstraZeneca.

AstraZeneca presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The presentation at the European Lung Cancer Conference (ELCC) in Geneva during the �Best of ELCC� session showed that the progression-free survival (PFS) benefit of 1st-line Tagrisso over the EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, was sustained throughout post-progression outcomes [Abstract #128O].

At the time of data cut-off, fewer patients on 1st-line Tagrisso had discontinued treatment compared to patients on the EGFR-TKI comparator arm (49% vs. 77%) and 29% received a subsequent treatment compared to 46% on the comparator arm. Median time to first subsequent therapy or death was 23.5 months (95% confidence interval [CI] 22.0, NC) for those treated with 1st-line Tagrisso vs. 13.8 months (95% CI 12.3, 15.7) for patients on erlotinib or gefitinib (hazard ratio [HR] 0.51, 95% CI 0.40, 0.64, p<0.0001). patients treated with 1st-line tagrisso experienced a longer time before discontinuation of egfr-tki therapy median 23.0 months 95 ci 19.5 nc compared to a median of 16.0 months 95 ci 14.8 18.6 for comparator arm patients which included patients who had crossed over to tagrisso in the 2nd line. 1st-line tagrisso patients had almost half the risk of second progression or death pfs2 compared to the comparator arm hr 0.58 95 ci 0.44 0.78 p><0.001). dr. david planchard associate professor of medicine thoracic tumour board gustave roussy france said: post-progression outcomes are increasingly recognised as important measures of efficacy for 1st-line cancer therapies and the consistency in risk reduction across these endpoints in flaura provides confidence in the data from the interim overall survival analysis. safety data for 1st-line tagrisso in flaura were in line with those observed in prior clinical trials.>