Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study

Garassino MC 1 , He Y 2 , Ahn MJ 3 , Orlov SV 4 , Potter V 5 , Kato T 6 Show all authors , Laskin J 7 , Voon PJ 8 , Reungwetwattana T 9 , Ramalingam SS 10 , Wu YL 11 , Albayaty M 12 , Cross SL 12 , Huang X 13 , Kulkarni D 14 , Cho BC 15

Affiliations 

  • 1 Department of Medicine, Hematology Oncology Section, Thoracic Oncology, University of Chicago Medicine & Biological Sciences, Chicago, IL 60637, USA. Electronic address: mgarassino@medicine.bsd.uchicago.edu
  • 2 Department of Respiratory Disease, Daping Hospital, Army Medical University, Chongqing, China
  • 3 Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
  • 4 Oncology Department, Pavlov First State Medical University of St Petersburg, St Petersburg, Russia
  • 5 Oncology Department, University Hospitals Coventry and Warwickshire, Coventry, UK
  • 6 Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan
  • 7 Department of Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada
  • 8 Department of Radiotherapy, Oncology and Palliative Care, Hospital Umum Sarawak, Kuching, Sarawak, Malaysia
  • 9 Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • 10 Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA, USA
  • 11 Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
  • 12 Global Patient Safety, Oncology R&D, AstraZeneca, Cambridge, UK
  • 13 Biometrics, Late-Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK
  • 14 Late-Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK
  • 15 Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
Lung Cancer, 2025 Jan 31;202:108417.
PMID: 40056874 DOI: 10.1016/j.lungcan.2025.108417

Abstract

INTRODUCTION: This post-hoc analysis of the registrational FLAURA study and AURA program reports long-term safety data in epidermal growth factor receptor-mutated (EGFRm), advanced non-small cell lung cancer (NSCLC) treated with osimertinib for ≥ 36 months.

METHODS: Patients from FLAURA who received first-line osimertinib and from the AURA program (AURA, AURA2, AURA3) who received ≥ second-line osimertinib were included. Patients received osimertinib 80 mg once daily. Safety data were analyzed in patients who remained on treatment for ≥ 36 months. The post-study global safety database captured investigator-reported serious adverse events (SAEs) in patients who continued osimertinib beyond final data cut-off (DCO) of the studies. Best response data were analyzed in patients on treatment for ≥ 54 months (FLAURA) or ≥ 36 months (AURA program).

RESULTS: In FLAURA, 76 (28 %) and 36 (13 %) of 267 patients received first-line osimertinib for ≥ 36 and ≥ 54 months, respectively; median exposure: 52.5 and 64.5 months, respectively. Across the AURA program,124 (16 %) of 799 patients received ≥ second-line osimertinib for ≥ 36 months; median exposure: 44.7 months. Investigators reported on-study SAEs in 17 % (FLAURA) and 35 % (AURA program) of patients who continued treatment for ≥ 36 months. Post-study incidences of SAEs were 11 % (FLAURA) and 21 % (AURA program). On-study, adverse events (AEs) of cardiac effects (indicative of cardiac failure; grouped term) occurred in 7 % (FLAURA) and 5 % (AURA program) of patients; AEs of interstitial lung disease (ILD; grouped term) occurred in 0 (FLAURA) and 1 (AURA program) patient. No post-study SAEs were reported for the grouped terms cardiac effects and ILD. Most patients treated for ≥ 54 months (FLAURA) and ≥ 36 months (AURA program) had a best on-study response of partial response.

CONCLUSION: This analysis demonstrated that long-term treatment with osimertinib of ≥ 36 months was well tolerated in patients with EGFRm advanced NSCLC.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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