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Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation-Positive
Jang Ho Lee1, Eun Young Kim2, Cheol-Kyu Park3
1Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Purpose:
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with EGFR T790M mutation-positive non-small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.
Materials And Methods:
Patients with confirmed EGFR T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.
Results:
A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.
Conclusion:
Osimertinib demonstrated its clinical effectiveness and survival benefit for EGFR T790M mutation-positive in Korean patients with no new safety signals.
Insights
Osimertinib effectively treats EGFR T790M-positive non-small cell lung cancer in Korean patients, showing significant progression-free survival and overall survival benefits with manageable side effects.
Area of Science:
- Oncology
- Pharmacology
- Clinical Medicine
Background:
- Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) requires effective treatment strategies.
- Osimertinib is a standard-of-care, but real-world data on its efficacy in complex treatment courses is limited.
- Understanding treatment outcomes in diverse patient populations is crucial for optimizing care.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of osimertinib in Korean patients with EGFR T790M-positive NSCLC.
- To assess outcomes in patients who previously received EGFR tyrosine kinase inhibitor (TKI) treatment.
- To identify factors influencing osimertinib treatment effectiveness.
Main Methods:
- Retrospective analysis of 558 Korean patients with confirmed EGFR T790M mutation after prior EGFR-TKI progression.
- Osimertinib 80 mg daily was administered.
- Primary endpoint: progression-free survival (PFS); Secondary endpoints: time-to-treatment discontinuation (TTD), treatment discontinuation due to adverse effects, and overall survival (OS).
Main Results:
- Median PFS was 14.2 months; median TTD was 15.0 months; median OS was 36.7 months.
- Investigator-assessed response rate was 55.2%.
- Benefits were consistent across subgroups, but hepatic metastases, plasma T790M presence, and shorter prior EGFR-TKI duration were poor predictors. Only 1.8% discontinued due to severe adverse effects, including pneumonitis.
Conclusions:
- Osimertinib demonstrates significant clinical effectiveness and survival benefits in Korean patients with EGFR T790M-positive NSCLC.
- The safety profile of osimertinib was confirmed with no new safety signals identified.
- Real-world data supports osimertinib as a valuable treatment option for this patient population.
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