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Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301
Ki Hyeong Lee1, Byoung Chul Cho2, Myung-Ju Ahn3
1Division of Medical Oncology, Department of Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
Purpose:
This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC).
Materials And Methods:
Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results:
In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment-related AEs occurred with lazertinib than gefitinib.
Conclusion:
Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.
Insights
Lazertinib significantly improved progression-free survival in Korean patients with EGFR-mutated non-small cell lung cancer compared to gefitinib. This study supports lazertinib as a new first-line treatment option with comparable safety.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Non-small cell lung cancer (NSCLC) with EGFR mutations (EGFRm) is a significant health concern.
- First-line treatment options for EGFRm NSCLC are continuously evolving.
- Personalized medicine approaches are crucial for optimizing patient outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of lazertinib versus gefitinib in Korean patients with EGFRm NSCLC.
- To analyze lazertinib's effectiveness as a first-line therapy in a specific patient subgroup.
- To compare progression-free survival (PFS) and safety profiles between lazertinib and gefitinib.
Main Methods:
- Subgroup analysis of the phase 3 LASER301 trial involving 172 Korean patients.
- Randomized 1:1 allocation to lazertinib (240 mg/day) or gefitinib (250 mg/day).
- Primary endpoint: investigator-assessed progression-free survival (PFS).
Main Results:
- Lazertinib demonstrated a median PFS of 20.8 months versus 9.6 months for gefitinib (HR, 0.41).
- Significant PFS benefit with lazertinib was observed across subgroups, including those with brain metastases and L858R mutations.
- Lazertinib exhibited a comparable safety profile to gefitinib, with numerically fewer severe adverse events.
Conclusions:
- Lazertinib offers a significant PFS benefit over gefitinib in Korean patients with untreated EGFRm NSCLC.
- The safety profile of lazertinib is consistent with previous findings and comparable to gefitinib.
- Lazertinib represents a promising new first-line treatment option for this patient population.
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