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• W3029877986 abstract "9571 Background: Lazertinib (YH25448) is a highly mutant-selective, irreversible 3 rd -generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets the activating EGFR mutations (Del19 and L858R), as well as the T790M mutation, while sparing wild type. Brain metastasis (BM) are common in patients (pts) with advanced NSCLC. Lazertinib showed a high blood-brain barrier penetration profile in preclinical studies. We report intracranial response data in pts with advanced NSCLC from a Phase I/II study of lazertinib (NCT03046992). Methods: Pts with advanced NSCLC, who had progressed after prior EGFR-TKI therapy, were enrolled in an open-label, multicenter, phase I/II study with dose-escalation, dose-expansion and dose-extension phases. Brain MRI was done in all pts at baseline. Pts with asymptomatic BM were eligible for enrollment. Intracranial anti-tumor activity of lazertinib was analysed in pts with BM present on baseline brain scan. Pre-defined intracranial endpoints included objective intracranial response rate (OIRR) and intracranial progression-free survival (IPFS) by independent central review (ICR). The brain metastasis full analysis population included pts with measurable and/or non-measurable BM lesion present on baseline brain scan; the brain metastasis population evaluable for response included only pts with measurable BM lesion. Results: As of 30 Sep 2019, a total of 181 pts received at least one dose of lazertinib 20-320 mg across 7 dose levels. Of those, 64 pts (56% female, median age 63, 86% T790M mutation positive by central testing) were included in the brain metastasis full analysis population; Intracranial disease control rate (IDCR) was 90.6% (58/64; 95% CI 83.5, 97.8) and median IPFS was not reached (95% CI 14.0, NR). In the brain metastasis population evaluable for response, a total of 22 pts were included; OIRR and IDCR were 54.5% (12/22; 95% CI 33.7, 75.4) and 90.9% (20/22; 95% CI 78.9, 100), respectively. In 13 pts (7.2%) out of 181 pts, brain was the first site of disease progression by existing and/or new lesions. Conclusions: Lazertinib demonstrated clinically meaningful activity against BM, aligned with preclinical data. Clinical trial information: NCT03046992 ." @default.
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• W3029877986 date "2020-05-20" @default.
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• W3029877986 title "Intracranial anti-tumor activity of lazertinib in patients with advanced NSCLC who progressed after prior EGFR TKI therapy: Data from a phase I/II study." @default.
• W3029877986 doi "https://doi.org/10.1200/jco.2020.38.15_suppl.9571" @default.
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