A phase 3 trial evaluating ensartinib in completely resected ALK-positive non-small-cell lung cancer (NSCLC) reported a strong disease-free survival benefit at 24 months. In patients with stage II to IIIB disease, 86.4% in the ensartinib arm were alive and disease-free versus 53.5% with placebo. Across the overall population, the same direction held: 87.3% alive and disease-free with ensartinib compared with 57.2% on placebo (hazard ratio 0.20; P<0.001). Overall survival data were immature, while grade 3-or-higher adverse events occurred in 35.8% versus 18.2% in the placebo group, with rash among the most common. The trial, ELEVATE (NCT05341583), supports ensartinib as a potential new standard for the adjuvant setting after adjuvant chemotherapy in ALK-positive disease. For clinicians and pipeline strategists, the magnitude of the DFS separation positions ensartinib as a contender for label expansion depending on final regulatory submissions. The reported effect size reinforces continued investor and development focus on targeted oral kinase inhibitors for earlier-stage, biomarker-defined NSCLC populations.
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