OS Data Update

TAGRISSO® (osimertinib) significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer

TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression1

 

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:

  • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
  • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

 

Safety considerations*

  • If ILD is diagnosed, TAGRISSO should be permanently discontinued and appropriate treatment initiated as necessary4
  • Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval. Treatment should be withheld in patients who develop a QTc interval >500 msec on at least 2 separate ECGs, and TAGRISSO should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia4
  • Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases ≥10% and a drop to <50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment. Based on the available clinical trial data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and TAGRISSO. In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered4
  • In patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye should be referred promptly to an ophthalmology specialist4
  • Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher. Close monitoring is recommended in these patients4
  • Based on its mechanism of action and preclinical data, TAGRISSO may cause foetal harm when administered to a pregnant woman. TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with TAGRISSO4

*Please refer to product labelling for more information.

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.