Please use this identifier to cite or link to this item:
https://hdl.handle.net/20.500.14365/5039
Title: | Central Nervous System Outcomes of Lazertinib Versus Gefitinib in Egfr-Mutated Advanced Nsclc: a Laser301 Subset Analysis | Authors: | Soo, Ross A. Cho, Byoung Chul Kim, Joo-Hang Ahn, Myung-Ju Lee, Ki Hyeong Zimina, Anastasia Cicin, Irfan |
Keywords: | Cns Lazertinib Nsclc Tki |
Publisher: | Elsevier Science inc | 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 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 objec- tive 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 sur- vival compared with gefitinib, with more durable responses. | Description: | Bondarenko, Igor/0000-0002-7071-2471; Cho, Byoung Chul/0000-0002-5562-270X; Kilickap, Saadettin/0000-0003-1637-7390 | URI: | https://doi.org/10.1016/j.jtho.2023.08.017 | ISSN: | 1556-0864 1556-1380 |
Appears in Collections: | PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection |
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