Background: NSCLC accounts for a significant proportion of global cancer mortality, with ALK-positive NSCLC constituting approximately 9% of cases. Ensartinib has demonstrated promising systemic and central CNS efficacy in clinical trials.
Methods: A systematic review and meta-analysis were performed following PRISMA guidelines, using PubMed, Web of Science, Cochrane, and Scopus databases. RCTs and cohort studies reporting outcomes such as OS, PFS, RR, and adverse events in ALK-positive NSCLC patients treated with ensartinib were included. Data were synthesized using CMA software, and heterogeneity was assessed using chi-square tests and I² statistics.
Results: Six studies encompassing 1,246 patients met the inclusion criteria. Pooled analysis revealed a RR of 56% (95% CI: 45–67%) and significant improvements in OS (Mean = 41.71 months, 95% CI: 31.64–51.77) and PFS (Mean = 8.88 months, 95% CI: 4.48–13.28). Common adverse events included rash (69%), nausea (19%), vomiting (15%), and transaminitis, with ALT (49%) and AST (42%) elevations.
Conclusions: Ensartinib exhibits significant efficacy in improving OS and PFS in ALK-positive NSCLC, with manageable adverse effects. Its robust systemic and CNS activity supports its clinical utility as a second-generation ALK inhibitor. Further studies with bigger, diverse populations are warranted to validate these findings and explore long-term outcomes.

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