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Lazertinib in pretreated EGFR T790M-mutated advanced non-small cell lung cancer: A real-world multicenter study
Hyunwook Kim1, Beung-Chul Ahn2, Jiyun Lee3
1Yonsei Cancer Center, Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Introduction:
Lazertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that provides a high level of selectivity for sensitizing and p.Thr790Met (T790M) EGFR mutations. We aimed to collect real-world data regarding the efficacy and safety of lazertinib.
Methods:
This study included patients treated with lazertinib for T790M-mutated non-small cell lung cancer who had previously been treated with an EGFR-TKI. The primary outcome measure was progression-free survival (PFS). Additionally, this study evaluated overall survival (OS), time-to-treatment failure (TTF), duration of response (DOR), objective response rate (ORR) and disease control rate (DCR). Drug safety was also assessed.
Results:
In a study of 103 patients, 90 received lazertinib as a second- or third-line therapy. The ORR and DCR were 62.1% and 94.2%, respectively. The median follow-up duration was 11.1 months, and the median PFS period was 13.9 (95% confidence interval [CI], 11.0-not reached [NR]) months. OS, DOR, and TTF had not yet been determined. In a subgroup of 33 patients with evaluable brain metastases, the intracranial DCR and ORR were 93.5% and 57.6%, respectively. The median intracranial PFS period was 17.1 (95% CI, 13.9-NR) months. Approximately 17.5% of patients had dose modification or discontinuation due to adverse events, with the most common being grade 1 or 2 paresthesia.
Conclusions:
The efficacy and safety of lazertinib were recapitulated in a real-world study reflecting routine clinical practice in Korea, showing durable disease control both systematically and intracranially, with manageable side effects.
Insights
Lazertinib demonstrates effective real-world efficacy in treating T790M-mutated non-small cell lung cancer, showing durable disease control and manageable side effects. This study confirms lazertinib
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Lazertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with high selectivity for sensitizing and T790M mutations.
- Real-world data is crucial for understanding the efficacy and safety of novel cancer therapies in routine clinical practice.
Purpose of the Study:
- To collect and analyze real-world data on the efficacy and safety of lazertinib in patients with non-small cell lung cancer (NSCLC) harboring the T790M mutation.
- To evaluate key efficacy endpoints including progression-free survival (PFS), overall survival (OS), time-to-treatment failure (TTF), duration of response (DOR), objective response rate (ORR), and disease control rate (DCR).
Main Methods:
- Retrospective analysis of 103 patients with T790M-mutated NSCLC previously treated with an EGFR-TKI.
- Ninety patients received lazertinib as second- or third-line therapy.
- Efficacy outcomes (PFS, OS, TTF, DOR, ORR, DCR) and safety (adverse events) were assessed.
Main Results:
- Objective response rate (ORR) was 62.1% and disease control rate (DCR) was 94.2% in the overall study population.
- Median progression-free survival (PFS) was 13.9 months. In a subgroup with brain metastases, intracranial ORR was 57.6% and intracranial DCR was 93.5%, with a median intracranial PFS of 17.1 months.
- Adverse events leading to dose modification or discontinuation occurred in 17.5% of patients, most commonly paresthesia.
Conclusions:
- Lazertinib demonstrated durable systemic and intracranial disease control in a real-world setting for T790M-mutated NSCLC patients.
- The safety profile of lazertinib was manageable, consistent with previous findings.
- This study supports the use of lazertinib in routine clinical practice for previously treated NSCLC patients with EGFR T790M mutations.
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