FINAL PROGRESSION-FREE SURVIVAL AND UPDATED OVERALL SURVIVAL DATA FOR TREATMENT-NAIVE ADVANCED ALK-POSITIVE NON-SMALL-CELL LUNG CANCER: ALEX STUDY RESULTS

Abstract

Targeted therapy has fundamentally transformed the treatment paradigm of anaplastic lymphoma kinase (ALK) positive non–small cell lung cancer (NSCLC), establishing tyrosine kinase inhibitors (TKIs) as the standard of care in the first-line setting. Data from the multicentric, phase III ALEX trial, with a median follow-up of 48.2 months, demonstrated a statistically significant superiority of alectinib over the first-generation TKI crizotinib. The median progression-free survival was 34.8 months in the alectinib group compared with 10.9 months in the crizotinib group. In addition to its systemic efficacy, alectinib exhibits substantial intracranial activity. Real-world evidence indicates high effectiveness in controlling both asymptomatic and symptomatic central nervous system (CNS) metastases. These findings support alectinib as one of the optimal first-line treatment options for ALK-positive NSCLC, ensuring durable disease control and improved survival outcomes.