On August 9th 2019, AstraZeneca announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of TAGRISSO (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.1
TAGRISSO showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting.1 The FLAURA trial met its primary endpoint in 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of TAGRISSO was consistent with its established profile.2
José Baselga, Executive Vice President, Oncology R&D said: “Today’s positive results show that TAGRISSO provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming TAGRISSO as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”3
AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.
TAGRISSO AS MONOTHERAPY IS INDICATED FOR:
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Please see full Summary of Product Characteristics (SmPC) here.
Adverse Event Reporting
Reporting suspected adverse events after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V of the SmPC. Adverse events should be reported. Please report adverse events at https://aereporting.astrazeneca.com/
References: 1. TAGRISSO significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer [press release]. Cambridge, UK: AstraZeneca Pharmaceuticals; August 9, 2019. https://www.astrazeneca.com/media-centre/pressreleases/2019/tagrisso-significantly-improves-overall-survival-in-the-phase-iii-flaura-trial-for-1st-line-egfr-mutated-non-small-cell-lung-cancer-09082019.html. 2. Soria J-C, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med. 2018;378:113-125. 3. Planchard D, Popat S, Kerr K, et al; on behalf of the ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(Suppl 4):iv192-iv237. 4. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2018.