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

Marina Chiara Garassino; Yong He; Myung Ju Ahn; Sergey V. Orlov; Vanessa Potter; Terufumi Kato; Janessa Laskin; Pei Jye Voon; Thanyanan Reungwetwattana; Suresh S. Ramalingam; Yi Long Wu; Muna Albayaty; Sarah L. Cross; Xiangning Huang; Dakshayini Kulkarni; Byoung Chul Cho

doi:10.1016/j.lungcan.2025.108417

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

Marina Chiara Garassino, Yong He, Myung Ju Ahn, Sergey V. Orlov, Vanessa Potter, Terufumi Kato, Janessa Laskin, Pei Jye Voon, Thanyanan Reungwetwattana, Suresh S. Ramalingam, Yi Long Wu, Muna Albayaty, Sarah L. Cross, Xiangning Huang, Dakshayini Kulkarni, Byoung Chul Cho

Department of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	108417
Journal	Lung Cancer
Volume	202
DOIs	https://doi.org/10.1016/j.lungcan.2025.108417
Publication status	Published - Apr 2025

Keywords

Long-term
NSCLC
Osimertinib
Tolerability

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.lungcan.2025.108417

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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. (2025). Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study. Lung Cancer, 202, Article 108417. https://doi.org/10.1016/j.lungcan.2025.108417

@article{fb0129e7913c461faf19e7d8e568daa4,

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

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.",

keywords = "Long-term, NSCLC, Osimertinib, Tolerability",

author = "Garassino, {Marina Chiara} and Yong He and Ahn, {Myung Ju} and Orlov, {Sergey V.} and Vanessa Potter and Terufumi Kato and Janessa Laskin and Voon, {Pei Jye} and Thanyanan Reungwetwattana and Ramalingam, {Suresh S.} and Wu, {Yi Long} and Muna Albayaty and Cross, {Sarah L.} and Xiangning Huang and Dakshayini Kulkarni and Cho, {Byoung Chul}",

note = "Publisher Copyright: {\textcopyright} 2025",

year = "2025",

month = apr,

doi = "10.1016/j.lungcan.2025.108417",

language = "English",

volume = "202",

journal = "Lung Cancer",

issn = "0169-5002",

publisher = "Elsevier Ireland Ltd",

}

Garassino, MC, He, Y, Ahn, MJ, Orlov, SV, Potter, V, Kato, T, Laskin, J, Voon, PJ, Reungwetwattana, T, Ramalingam, SS, Wu, YL, Albayaty, M, Cross, SL, Huang, X, Kulkarni, D & Cho, BC 2025, 'Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study', Lung Cancer, vol. 202, 108417. https://doi.org/10.1016/j.lungcan.2025.108417

TY - JOUR

T1 - Osimertinib long-term tolerability in patients with EGFRm NSCLC enrolled in the AURA program or FLAURA study

AU - Garassino, Marina Chiara

AU - He, Yong

AU - Ahn, Myung Ju

AU - Orlov, Sergey V.

AU - Potter, Vanessa

AU - Kato, Terufumi

AU - Laskin, Janessa

AU - Voon, Pei Jye

AU - Reungwetwattana, Thanyanan

AU - Ramalingam, Suresh S.

AU - Wu, Yi Long

AU - Albayaty, Muna

AU - Cross, Sarah L.

AU - Huang, Xiangning

AU - Kulkarni, Dakshayini

AU - Cho, Byoung Chul

PY - 2025/4

Y1 - 2025/4

N2 - 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.

AB - 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.

KW - Long-term

KW - NSCLC

KW - Osimertinib

KW - Tolerability

UR - http://www.scopus.com/inward/record.url?scp=86000133675&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2025.108417

DO - 10.1016/j.lungcan.2025.108417

M3 - Article

AN - SCOPUS:86000133675

SN - 0169-5002

VL - 202

JO - Lung Cancer

JF - Lung Cancer

M1 - 108417

ER -

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

Abstract

Keywords

UN SDGs

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