Phase III FLAURA trial full results support potential of Tagrisso (osimertinib) as a new standard of care for EGFR mutated NSCLC.- AstraZeneca
AstraZeneca has presented the full results of the Phase III FLAURA trial, which support the clear potential of Tagrisso (osimertinib) as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Results of the Phase III FLAURA trial demonstrate a superior, clinically-meaningful PFS advantage with osimertinib compared with current SoC EGFR-TKIs (erlotinib or gefitinib).
Additional highlights from the FLAURA data include:- Superior progression-free survival (PFS): Patients on osimertinib had less than half the risk of progression or death compared with patients on erlotinib or gefitinib (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.37-0.57; p<0.0001). The median PFS was 18.9 months for patients on osimertinib vs 10.2 months for patients in the comparator arm.
- Clinically-meaningful preliminary overall survival (OS) data at 25% maturity: The hazard ratio for OS was 0.63 (95% CI: 0.45-0.88; p=0.0068) favouring osimertinib. Overall survival data were 25% mature at the time of the interim analysis (21% of the patients on osimertinib had died and 30% of the patients on the comparator arm had died). The p-value of 0.0068 was not below the threshold of 0.0015 required for statistical significance at the current level of maturity. A final OS analysis is planned at a later stage.
- PFS improvements consistent across subgroups: Improvements in PFS with osimertinib were consistent across all pre-specified patient subgroups, with at least a 40% reduction in the risk of progression or death, including in patients with/without central nervous system (CNS) metastases at study entry, Asian/non-Asian patients, patients with/without prior smoking history, and patients with exon 19 deletion/L858R.
- Impressive duration of response (DoR) and objective response rate (ORR): Patients treated with osimertinib had more than double the median DoR than those on the comparator arm (17.2 months vs. 8.5 months), and an ORR (a measurement of tumour shrinkage) of 80% vs. 76% with the comparator arm (odds ratio 1.28 [0.85-1.93], p=0.2335).
Data presented at ESMO Congress Madrid.
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