2022 World Conference on Lung Cancer (ePosters)-EP08.02-108. Osimertinib Long-Term Tolerability in Patients with EGFRm NSCLC Enrolled in the AURA Program or FLAURA Study

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This post-hoc analysis of the FLAURA trial and AURA program aimed to report long-term safety data in patients with epidermal growth factor receptor mutant-positive (EGFRm) advanced non-small cell lung cancer (NSCLC) treated with osimertinib 80 mg once daily (QD) for 36 months. Osimertinib is a third-generation oral EGFR tyrosine kinase inhibitor that has been approved for the treatment of EGFRm NSCLC. <br /><br />The analysis included patients from the AURA program (AURA, AURA2, and AURA3 trials) who received second-line osimertinib and patients from the FLAURA trial who received first-line osimertinib. Safety data were analyzed in patients who remained on treatment for 36 months. The post-study global safety database was used to capture serious adverse events (SAEs) in patients who continued osimertinib treatment beyond the final data cut-off of the respective trials. Best response data based on response evaluation criteria in solid tumors (RECIST) v1.1 was also assessed.<br /><br />The results showed that osimertinib was generally well-tolerated in patients receiving long-term treatment of 36 months or more. In terms of safety, any SAEs were reported in 17% of patients from the FLAURA trial and 35% of patients from the AURA program who remained on osimertinib treatment for 36 months. Treatment-related SAEs were reported in 3% of patients from the FLAURA trial and 5% of patients from the AURA program. No incidences of ILD/non-infectious pneumonitis or QTc elongation were reported.<br /><br />In terms of efficacy, the majority of patients with long-term exposure to osimertinib had a best response of a partial response, indicating a reduction in tumor size.<br /><br />The analysis has some limitations, including the limited data available and the potential for missing data in the post-study global safety database. However, these findings suggest that patients receiving long-term osimertinib treatment have a low risk of serious side effects. The results highlight the tolerability of osimertinib in EGFRm NSCLC patients and provide valuable information for the clinical management of these patients.

Asset Subtitle

Marina Chiara Garassino

Meta Tag

Speaker Marina Chiara Garassino

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

post-hoc analysis

FLAURA trial

AURA program

long-term safety data

epidermal growth factor receptor mutant-positive

advanced non-small cell lung cancer

osimertinib

oral EGFR tyrosine kinase inhibitor

serious adverse events

response evaluation criteria in solid tumors