Osimertinib (Tagrisso®) for the initial treatment of EGFR-mutated advanced non–small-cell lung cancer (NSCLC)

McGahan L
Record ID 32018000300
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
Year Published: 2018
URL for additional information: http://eprints.aihta.at/1160/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Therapeutics
  • Lung Neoplasms
  • Pharmacology
  • Carcinoma, Non-Small-Cell Lung
  • Mutation
  • Antineoplastic Agents
  • ErbB Receptors
  • Osimertinib
  • Tagrisso®
  • non-small-cell lung cancer (NSCLC)
  • initial therapy
  • EGFR mutation
  • EGFR tyrosine kinase inhibitor (EGFR-TKI)
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
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.