2024 World Conference on Lung Cancer (WCLC) - Posters-P1.12B.01 Intracranial Efficacy of Lorlatinib via RANO-BM in ALK-Fusion NSCLC with CNS Metastases: A Retrospective, Multicenter Study

P1.12B.01 Intracranial Efficacy of Lorlatinib via RANO-BM in ALK-Fusion NSCLC with CNS Metastases: A Retrospective, Multicenter Study

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This retrospective, multicenter study examines the intracranial efficacy of lorlatinib, a targeted therapy, in treating patients with ALK-positive non-small cell lung cancer (NSCLC) who have central nervous system (CNS) metastases. Specifically, it assesses lorlatinib's impact on brain metastases (BMs) and leptomeningeal metastases (LMs) using the RANO-BM criteria.<br /><br />**Study Design & Participants:**<br />The study enrolled 27 adults with metastatic ALK-positive NSCLC and either BMs or LMs, who began treatment with lorlatinib between July 2022 and July 2023. Follow-up was conducted for a median of nine months. Most patients were heavily pretreated with a median of three prior lines of therapy.<br /><br />**Endpoints:**<br />Primary focus was on the intracranial objective response rate (iORR). Secondary outcomes included median intracranial progression-free survival (miPFS), intracranial disease control rate (iDCR), median overall survival (mOS), and safety profiles.<br /><br />**Results:**<br />- The iORR among all patients was 44.4%, including an 11.1% complete response rate.<br />- Patients previously treated with second-generation ALK inhibitors had an iORR of 36.4%.<br />- Among those with baseline detectable BMs, the iORR was 57.9%.<br />- The overall intracranial disease control rate was 66.7%, with an miPFS of 8.6 months and mOS of 16.1 months.<br /><br />For patients with LMs (and concomitant BMs):<br />- iORR was 20%.<br />- iDCR was 60.0%, miPFS was 4.0 months, and mOS was 8.6 months.<br /><br />**Safety:**<br />Common adverse events (AEs) included hypercholesterolemia, hypertriglyceridemia, and edema. Grade 3 AEs were reported for hypercholesterolemia (3.7%) and hypertriglyceridemia (11.1%). No grade 4 or higher AEs were observed.<br /><br />**Conclusion:**<br />This study is the first real-world study in China to show that lorlatinib provides significant intracranial efficacy in treating ALK-positive NSCLC patients with CNS metastases, with a manageable safety profile.

Asset Subtitle

Juan Li

Meta Tag

Speaker Juan Li

Topic Metastatic NSCLC – Targeted Therapy

Keywords

lorlatinib

ALK-positive NSCLC

intracranial efficacy

central nervous system metastases

brain metastases

leptomeningeal metastases

RANO-BM criteria

intracranial objective response rate

safety profile

China