The role of osimertinib in the therapeutic pathway of EGFR-mutated NSCLC: results from an Italian Delphi Consensus

Introduction: Osimertinib has become a key therapeutic option across multiple disease settings in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), supported by evidence from the AURA3, FLAURA, ADAURA, FLAURA2, and LAURA trials. However, uncertainties remain regarding its impact on quality of life (QoL), tolerability, and positioning as standard of care in clinical practice. This study assessed agreement among Italian experts on the role of osimertinib across the therapeutic continuum of EGFR-mutated NSCLC using a Delphi consensus methodology.Methods: An 11-member Steering Committee developed and validated 35 statements covering four domains: standard of care, QoL, treatment manageability and adverse event management. The statements were evaluated through a two-round Delphi survey by an Italian Expert Panel of 28 clinicians experienced in managing EGFR-mutated NSCLC. Consensus was defined as ≥ 70% agreement (Likert scores 4-5).Results: Among the initial 26 statements, the completion rate was 100% across both rounds, with consensus achieved for all statements. For the additional 9 statements, the completion rate was 89.3%, and consensus was again reached for all statements. High agreement supported osimertinib as a standard therapeutic option in advanced, adjuvant and unresectable stage III EGFR-mutated NSCLC. Experts also recognized its favorable impact on central nervous system disease control, QoL, treatment tolerability and long-term clinical manageability.Conclusion: This Italian Delphi Consensus confirms broad expert agreement on the central role of osimertinib across the therapeutic continuum of EGFR-mutated NSCLC, supporting its use as a standard of care in multiple clinical settings.