Assessing the efficacy of ALK inhibitors in ALK-positive non-small cell lung cancer: A real-world data analysis.

e20688 Background: Anaplastic lymphoma kinase (ALK) positive lung cancer represents a subtype with specific therapeutic targets. ALK inhibitors have significantly improved outcomes for these patients. However, real-world evidence on the efficacy and patterns of use of ALK inhibitors in Russia remains sparse. This study aims to fill this gap by analyzing the characteristics and outcomes of patients treated with ALK inhibitors in Moscow. Methods: We conducted a retrospective observational study of 327 patients diagnosed with ALK-positive lung cancer between 2019 and 2024 in Moscow, Russia. Data were collected from medical records including patient demographics, clinical characteristics, specific ALK inhibitors used, and treatment outcomes, including overall survival (OS), progression-free survival (PFS).. Descriptive statistics and Kaplan-Meier survival analysis were employed to assess the impact of ALK inhibitors on patient outcomes. Results: The cohort consisted of 203 women (62.1%) and 124 men (37.9%), with 83 non-smokers (74.1%). Most patients received targeted therapy (n=252, 77.3%) as first-line treatment for metastatic disease, with fewer undergoing chemotherapy (n=65, 19.9%) or other regimens (n=9, 2.7%). Alectinib and crizotinib were the most commonly used ALK inhibitors, administered to 41.7% and 58.3% patients, respectively. The median follow-up duration was 44 months (95% CI: 39.3–48.8 months). The 5-year OS rate for the entire cohort was 51% (95% CI: 40.2%–59.8%) with 5-year OS in the alectinib group at 67% compared to 46% in the crizotinib group, HR=0.69 (95% CI [0.45-1.05], p=0.085). The 5-year PFS was 22% (95% CI: 12.2%–29.8%), with alectinib demonstrating superior long-term disease control at 50% versus 17% for crizotinib, HR = 0.47 (95% CI [0.32-0.69], p<0.001). Conclusions: This study represents the largest dataset from Russia on the treatment of ALK-positive lung cancer patients with ALK inhibitors, confirming findings similar to the international ALEX study. Our results reinforce the efficacy of ALK inhibitors in a real-world setting and suggest that future generations of these agents could provide even greater benefits. The consistency between these findings and those of controlled trials underscores the potential of ALK inhibitors in improving clinical outcomes for this patient population.