Soo, Ross A. and Cho, Byoung Chul and Kim, Joo-Hang and Ahn, Myung-Ju and Lee, Ki Hyeong and Zimina, Anastasia and Orlov, Sergey and Bondarenko, Igor and Lee, Yun-Gyoo and Lim, Yueh Ni and Lee, Sung Sook and Lee, Kyung-Hee and Pang, Yong Kek and Fong, Chin Heng and Kang, Jin Hyoung and Lim, Chun Sen and Danchaivijitr, Pongwut and Kilickap, Saadettin and Yang, James Chih-Hsin and Arslan, Cagatay and Lee, Hana and Park, Seong Nam and Cicin, Irfan (2023) Central nervous system outcomes of lazertinib versus gefitinib in EGFR-mutated advanced NSCLC: A LASER301 subset analysis. Journal of Thoracic Oncology, 18 (12). pp. 1756-1766. ISSN 1556-0864, DOI https://doi.org/10.1016/j.jtho.2023.08.017.
Full text not available from this repository.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.
| Item Type: | Article |
|---|---|
| Funders: | Yuhan |
| Uncontrolled Keywords: | CNS; Lazertinib; NSCLC; TKI |
| Subjects: | R Medicine |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 26 Oct 2025 05:01 |
| Last Modified: | 26 Oct 2025 05:01 |
| URI: | http://eprints.um.edu.my/id/eprint/48087 |
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