WCLC 2025 - Posters & ePosters-PT1.07.02 Neoadjuvant Ensartinib for ALK-Positive (ALK+) Non-Small Cell Lung Cancer (NSCLC): A Multicenter, Real-World Study

PT1.07.02 Neoadjuvant Ensartinib for ALK-Positive (ALK+) Non-Small Cell Lung Cancer (NSCLC): A Multicenter, Real-World Study

Back to course

Pdf Summary

This multicenter retrospective real-world study evaluated the efficacy and safety of neoadjuvant ensartinib, a potent ALK inhibitor, in patients with resectable ALK-positive stage I-III non-small cell lung cancer (NSCLC) in China from June 2023 to July 2024. Eligible patients had histologically or cytologically confirmed ALK-positive NSCLC, were aged 18 or older, had not received prior ALK tyrosine kinase inhibitors, and underwent complete surgical resection after at least one cycle of neoadjuvant ensartinib either as monotherapy or combined with chemotherapy.<br /><br />The primary endpoint was the major pathological response (MPR) rate, while secondary endpoints included pathological complete response (pCR), objective response rate (ORR), 1-year disease-free survival (DFS) rate, DFS, and overall survival (OS). Results showed a high ORR of 77.8%, with encouraging MPR and pCR rates. Adverse events (AEs) were mostly mild to moderate; the most common treatment-emergent AE was rash (77.8%), and no fatal or severe AEs occurred. One patient experienced a grade 3 AE (leukopenia), and three patients required dose reductions due to AEs.<br /><br />The findings demonstrate that neoadjuvant ensartinib offers promising antitumor activity with an acceptable safety profile in ALK-positive resectable NSCLC. However, survival data remain immature, requiring longer follow-up to confirm if high pathological response rates translate into long-term benefits. Additionally, further research is needed to determine the additive value of chemotherapy when combined with ensartinib.<br /><br />In conclusion, this study provides preliminary evidence supporting neoadjuvant ensartinib as a feasible perioperative therapy option for stage I-III ALK-positive NSCLC patients, potentially improving cure chances. Despite limitations inherent to its retrospective design, these real-world results contribute valuable insights into ALK-targeted neoadjuvant treatment.

Asset Subtitle

Xi Zhang

Meta Tag

Speaker Xi Zhang

Topic Early-Stage Non-small Cell Lung Cancer

Keywords

neoadjuvant ensartinib

ALK-positive NSCLC

non-small cell lung cancer

major pathological response

pathological complete response

objective response rate

disease-free survival

overall survival

treatment-emergent adverse events

perioperative therapy