Cancer Res Treat.  2024 Jan;56(1):48-60. 10.4143/crt.2023.453.

Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset

• Lee KH
• Cho BC
• Ahn MJ
• Lee YG
• Lee Y
• Lee JS
• Kim JH
• Min YJ
• Lee GW
• Lee SS
• Lee KH
• Ko YH
• Shim BY
• Kim SW
• Shin SW
• Choi JH
• Kim DW
• Cho EK
• Park KU
• Kim JS
• Chun SH
• Wang J
• Choi S
• Kang JH

• KMID: 2550322
• DOI: http://doi.org/10.4143/crt.2023.453

Abstract

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.

Keyword

Non-small-cell lung carcinoma; Lazertinib; mutation

Figure

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  Fig. 1 Patient disposition. DCO, data cutoff.

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  Fig. 2 Kaplan-Meier estimates of investigator-assessed progression-free survival (PFS) by treatment group. CI, confidence interval; HR, hazard ratio.

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  Fig. 3 Hazard ratios for progression or death in predefined patient subgroups. Subgroup categories with less than 20 events were excluded from the analysis. CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; WHO, World Health Organization.

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  Fig. 4 Kaplan-Meier estimates of investigator-assessed progression-free survival (PFS): (A) patients with brain metastases at study entry and (B) patients without brain metastases at study entry. CI, confidence interval; NR, not reached.

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  Fig. 5 Kaplan-Meier estimates of investigator-assessed progression-free survival (PFS): (A) patients with Ex19del mutation and (B) patients with L858R mutation. CI, confidence interval; NR, not reached.

Reference

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