Data from Pharmawand - Curated by EPG Health - Date added 14 April 2018
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.0>