Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301
Issued Date
2023-09-10
Resource Type
eISSN
15277755
Scopus ID
2-s2.0-85170112349
Pubmed ID
37379502
Journal Title
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume
41
Issue
26
Start Page
4208
End Page
4217
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology Vol.41 No.26 (2023) , 4208-4217
Suggested Citation
Cho B.C., Ahn M.J., Kang J.H., Soo R.A., Reungwetwattana T., Yang J.C.H., Cicin I., Kim D.W., Wu Y.L., Lu S., Lee K.H., Pang Y.K., Zimina A., Fong C.H., Poddubskaya E., Sezer A., How S.H., Danchaivijitr P., Kim Y., Lim Y., An T., Lee H., Byun H.M., Zaric B. Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Vol.41 No.26 (2023) , 4208-4217. 4217. doi:10.1200/JCO.23.00515 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/90011
Title
Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301
Author's Affiliation
The Catholic University of Korea Seoul St. Mary's Hospital
Siriraj Hospital
Yonsei Cancer Hospital
Chungbuk National University Hospital
Hospital Pulau Pinang
Yuhan Corporation
Shanghai Chest Hospital
National Taiwan University Hospital
Guangdong Provincial People’s Hospital of Southern Medical University
Faculty of Medicine, University of Novi Sad
National University Hospital
Samsung Medical Center, Sungkyunkwan university
Faculty of Medicine Ramathibodi Hospital, Mahidol University
University of Malaya Medical Centre
Sechenov First Moscow State Medical University
Trakya Üniversitesi
Seoul National University College of Medicine
Adana Baskent Hospital
Hospital Tengku Ampuan Afzan
Siriraj Hospital
Yonsei Cancer Hospital
Chungbuk National University Hospital
Hospital Pulau Pinang
Yuhan Corporation
Shanghai Chest Hospital
National Taiwan University Hospital
Guangdong Provincial People’s Hospital of Southern Medical University
Faculty of Medicine, University of Novi Sad
National University Hospital
Samsung Medical Center, Sungkyunkwan university
Faculty of Medicine Ramathibodi Hospital, Mahidol University
University of Malaya Medical Centre
Sechenov First Moscow State Medical University
Trakya Üniversitesi
Seoul National University College of Medicine
Adana Baskent Hospital
Hospital Tengku Ampuan Afzan
Other Contributor(s)
Abstract
PURPOSE: Lazertinib is a potent, CNS-penetrant, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This global, phase III study (LASER301) compared lazertinib versus gefitinib in treatment-naïve patients with EGFR-mutated (exon 19 deletion [ex19del]/L858R) locally advanced or metastatic non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were 18 years and older with no previous systemic anticancer therapy. Neurologically stable patients with CNS metastases were allowed. Patients were randomly assigned 1:1 to lazertinib 240 mg once daily orally or gefitinib 250 mg once daily orally, stratified by mutation status and race. The primary end point was investigator-assessed progression-free survival (PFS) by RECIST v1.1. RESULTS: Overall, 393 patients received double-blind study treatment across 96 sites in 13 countries. Median PFS was significantly longer with lazertinib than with gefitinib (20.6 v 9.7 months; hazard ratio [HR], 0.45; 95% CI, 0.34 to 0.58; P < .001). The PFS benefit of lazertinib over gefitinib was consistent across all predefined subgroups. The objective response rate was 76% in both groups (odds ratio, 0.99; 95% CI, 0.62 to 1.59). Median duration of response was 19.4 months (95% CI, 16.6 to 24.9) with lazertinib versus 8.3 months (95% CI, 6.9 to 10.9) with gefitinib. Overall survival data were immature at the interim analysis (29% maturity). The 18-month survival rate was 80% with lazertinib and 72% with gefitinib (HR, 0.74; 95% CI, 0.51 to 1.08; P = .116). Observed safety of both treatments was consistent with their previously reported safety profiles. CONCLUSION: Lazertinib demonstrated significant efficacy improvement compared with gefitinib in the first-line treatment of EGFR-mutated advanced NSCLC, with a manageable safety profile.