Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study
Issued Date
2025-04-01
Resource Type
ISSN
01695002
eISSN
18728332
Scopus ID
2-s2.0-86000133675
Journal Title
Lung Cancer
Volume
202
Rights Holder(s)
SCOPUS
Bibliographic Citation
Lung Cancer Vol.202 (2025)
Suggested Citation
Garassino M.C., He Y., Ahn M.J., Orlov S.V., Potter V., Kato T., Laskin J., Voon P.J., Reungwetwattana T., Ramalingam S.S., Wu Y.L., Albayaty M., Cross S.L., Huang X., Kulkarni D., Cho B.C. Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study. Lung Cancer Vol.202 (2025). doi:10.1016/j.lungcan.2025.108417 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/106722
Title
Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study
Author's Affiliation
Yonsei Cancer Hospital
Hospital Umum Sarawak
Guangdong Provincial People’s Hospital of Southern Medical University
British Columbia Cancer Agency
Army Medical University
Samsung Medical Center, Sungkyunkwan university
Kanagawa Cancer Center Research Institute
Faculty of Medicine Ramathibodi Hospital, Mahidol University
The University of Chicago Medicine
University Hospitals Coventry and Warwickshire NHS Trust
AstraZeneca
Pavlov University
Emory University School of Medicine
Hospital Umum Sarawak
Guangdong Provincial People’s Hospital of Southern Medical University
British Columbia Cancer Agency
Army Medical University
Samsung Medical Center, Sungkyunkwan university
Kanagawa Cancer Center Research Institute
Faculty of Medicine Ramathibodi Hospital, Mahidol University
The University of Chicago Medicine
University Hospitals Coventry and Warwickshire NHS Trust
AstraZeneca
Pavlov University
Emory University School of Medicine
Corresponding Author(s)
Other Contributor(s)
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.