Central Nervous System Outcomes of Lazertinib Treatment in EGFR-Mutated Advanced NSCLC: Pooled Analysis From LASER201 and LASER301
Year: 2025
Type: article
Abstract: BACKGROUND: Lazertinib, a brain-penetrant, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), significantly improved efficacy in patients with treatment-naïve, EGFR-mutated advanced non-small cell lung cancer (NSCLC) in the clinical trials, LASER201 and LASER301. This analysis evaluated the efficacy and safety of lazertinib in patients with EGFR-mutated NSCLC and CNS metastases using pooled data from LASER201 and LASER301. PATIENTS AND METHODS: Patients with treatment-naïve, EGFR-mutated advanced NSCLC and stable CNS metastases who were treated with lazertinib in a cohort of LASER201 and LASER301 were included. Intracranial progression-free survival (iPFS), intracranial objective response rate (iORR), intracranial disease control rate (iDCR), intracranial duration of response (iDoR), and treatment-emergent adverse events (TEAEs) were assessed. RESULTS: A total of 64 patients were included in the intracranial full analysis set (iFAS); 24 patients had at least 1 measurable CNS lesion at baseline. The median iPFS was 27.7 months (95% CI: 15.7-32.8) in the iFAS population. For patients with at least 1 measurable CNS lesion at baseline, iORR was 92% and iDCR was 96%. The median iDoR was 26.5 months (95% CI: 8.3-30.1). TEAEs were reported in 98% of patients in the iFAS population, with grade ≥3 TEAEs occurring in 55% of patients. The most common TEAEs were paresthesia (47%), rash (41%), and pruritus (36%). CONCLUSION: In this pooled analysis of LASER201 and LASER301, lazertinib demonstrated a clinically meaningful treatment benefit and consistent safety profile in patients with EGFR-mutated advanced NSCLC and CNS metastases.
Source: Clinical Lung Cancer
Institutions: National Taiwan University, National Taiwan University Hospital, Samsung Medical Center, Sungkyunkwan University, CHA University Bundang Medical Center, CHA University, Kangbuk Samsung Hospital, National Cancer Center, National Cancer Center Hospital, Chungbuk National University, Yeungnam University Medical Center, Chungbuk National University Hospital, Yeungnam University, Seoul National University, Seoul National University Hospital, Inje University Haeundae Paik Hospital, Sultan Ismail Specialist Hospital, Sarawak General Hospital, University of Ulsan, Ulsan University Hospital, First Pavlov State Medical University of St. Petersburg, Yuhan (South Korea), Yonsei University, Yonsei University Health System, Yonsei Cancer Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,200
Funder: Yuhan
OpenAlex ID: W4413889915