Authors' results and conclusions: Overall, FLAURA is the first phase III, randomised, double-blind, comparative trial to demonstrate that osimertinib substantially increases progression-free survival (PFS) and lowers the risk of disease progression compared to first-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) as initial therapy for EGFR-mutated advanced non-small cell lung cancer (NSCLC). The PFS benefit was consistent across subgroups. OS and QoL data are needed to confirm patients achieve a clinically relevant benefit over time despite favourable tolerability. Currently, the optimal therapeutic sequencing of different generations of EGFR-TKI remains unknown. However osimertinib holds efficacy for brain metastases which represent a significant clinical problem in patients treated with first and second generation EGFR-TKIs.

Authors' recommendations: Further analyses are necessary to fully characterise the resistance mechanisms to osimertinib for targeting by fourth-generation inhibitors. A new class of inhibitors, designed to target a triple mutation thought to confer resistance to fourth-generation EGFR-TKIs, is also under development.

Project Status: Completed

URL for project: https://aihta.at/page/horizon-scanning-in-der-onkologie/en

Year Published: 2018

URL for published report: http://eprints.aihta.at/1160/1/DSD_HSO_Nr.80.pdf

URL for additional information: http://eprints.aihta.at/1160/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Austria

Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment

Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99

Contact Name: tarquin.mittermayr@aihta.at

Contact Email: office@aihta.at