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

dc.contributor.authorSoo, R.A.
dc.contributor.authorCho, B.C.
dc.contributor.authorKim, J.-H.
dc.contributor.authorAhn, M.-J.
dc.contributor.authorLee, K.H.
dc.contributor.authorZimina, A.
dc.contributor.authorOrlov S.
dc.date.accessioned2024-05-19T14:33:39Z
dc.date.available2024-05-19T14:33:39Z
dc.date.issued2023
dc.departmentİstinye Üniversitesien_US
dc.description.abstractIntroduction: 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. © 2023 International Association for the Study of Lung Canceren_US
dc.description.sponsorshipYuhanen_US
dc.description.sponsorshipThis study was funded by Yuhan Corporation . Medical writing assistance was funded by Yuhan Corporation and provided by Michelle Hughes, BSc, and Jill E. Kolesar, PhD, of Lumanity Communications Inc. The authors would like to thank all the patients who participated in this study and their families and caregivers. The authors would also like to thank the physicians and nurses who cared for the patients and the staff at the clinical sites.en_US
dc.identifier.doi10.1016/j.jtho.2023.08.017
dc.identifier.endpage1766en_US
dc.identifier.issn1556-0864
dc.identifier.issue12en_US
dc.identifier.pmid37865896en_US
dc.identifier.scopus2-s2.0-85177597078en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage1756en_US
dc.identifier.urihttps://doi.org/10.1016/j.jtho.2023.08.017
dc.identifier.urihttps://hdl.handle.net/20.500.12713/4298
dc.identifier.volume18en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Inc.en_US
dc.relation.ispartofJournal of Thoracic Oncologyen_US
dc.relation.publicationcategoryKonferans Öğesi - Uluslararası - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.snmz20240519_kaen_US
dc.subjectCnsen_US
dc.subjectLazertiniben_US
dc.subjectNsclcen_US
dc.subjectTkıen_US
dc.titleCentral Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysisen_US
dc.typeConference Objecten_US

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