Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis

Soo R.A.; Cho B.C.; Kim J.H.; Ahn M.J.; Lee K.H.; Zimina A.; Orlov S.; Bondarenko I.; Lee Y.G.; Lim Y.N.; Lee S.S.; Pang Y.K.; Fong C.H.; Kang J.H.; Lim C.S.; Danchaivijitr P.; Kilickap S.; Yang J.C.H.; Arslan C.; Lee H.; Park S.N.; Cicin I.

Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis

Issued Date

2023-12-01

Resource Type

Conference Paper

ISSN

15560864

eISSN

15561380

DOI

10.1016/j.jtho.2023.08.017

Scopus ID

2-s2.0-85177597078

Pubmed ID

37865896

Journal Title

Journal of Thoracic Oncology

Volume

18

Issue

12

Start Page

1756

End Page

1766

Rights Holder(s)

SCOPUS

Bibliographic Citation

Journal of Thoracic Oncology Vol.18 No.12 (2023) , 1756-1766

Suggested Citation

Soo R.A., Cho B.C., Kim J.H., Ahn M.J., Lee K.H., Zimina A., Orlov S., Bondarenko I., Lee Y.G., Lim Y.N., Lee S.S., Lee K.H., Pang Y.K., Fong C.H., Kang J.H., Lim C.S., Danchaivijitr P., Kilickap S., Yang J.C.H., Arslan C., Lee H., Park S.N., Cicin I. Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis. Journal of Thoracic Oncology Vol.18 No.12 (2023) , 1756-1766. 1766. doi:10.1016/j.jtho.2023.08.017 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/91416

Title

Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis

Other Contributor(s)

Mahidol University

Abstract

Introduction: Lazertinib, a third-generation mutant-selective EGFR tyrosine kinase inhibitor, improved progression-free survival compared with gefitinib in the phase 3 LASER301 study (ClinicalTrials.gov Identifier: NCT04248829). Here, we report the efficacy of lazertinib and gefitinib in patients with baseline central nervous system (CNS) metastases. Methods: Treatment-naive patients with EGFR–mutated advanced NSCLC were randomized one-to-one to lazertinib (240 mg/d) or gefitinib (250 mg/d). Patients with asymptomatic or stable CNS metastases were included if any planned radiation, surgery, or steroids were completed more than 2 weeks before randomization. For patients with CNS metastases confirmed at screening or subsequently suspected, CNS imaging was performed every 6 weeks for 18 months, then every 12 weeks. End points assessed by blinded independent central review and Response Evaluation Criteria in Solid Tumors version 1.1 included intracranial progression-free survival, intracranial objective response rate, and intracranial duration of response. Results: Of the 393 patients enrolled in LASER301, 86 (lazertinib, n = 45; gefitinib, n = 41) had measurable and or non-measurable baseline CNS metastases. The median intracranial progression-free survival in the lazertinib group was 28.2 months (95% confidence interval [CI]: 14.8–28.2) versus 8.4 months (95% CI: 6.7–not reached [NR]) in the gefitinib group (hazard ratio = 0.42, 95% CI: 0.20–0.89, p = 0.02). Among patients with measurable CNS lesions, the intracranial objective response rate was numerically higher with lazertinib (94%; n = 17) versus gefitinib (73%; n = 11, p = 0.124). The median intracranial duration of response with lazertinib was NR (8.3–NR) versus 6.3 months (2.8–NR) with gefitinib. Tolerability was similar to the overall LASER301 population. Conclusions: In patients with CNS metastases, lazertinib significantly improved intracranial progression-free survival compared with gefitinib, with more durable responses.

Keyword(s)

Medicine

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/91416

Collections

Scopus 2023

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