In a Phase 3 trial reported in the medical literature, ensartinib improved disease-free survival in patients with completely resected ALK-positive stage IB to IIIB non–small-cell lung cancer (NSCLC). Patients received ensartinib 225 mg once daily or placebo for 24 months after adjuvant chemotherapy. At 24 months, the proportion of patients alive and disease-free was 86.4% with ensartinib versus 53.5% with placebo in stage II to IIIB disease, with a hazard ratio of 0.20 (P<0.001). In the overall population, rates were 87.3% versus 57.2% (HR 0.20; P<0.001). Overall survival data were immature. Grade 3 or higher adverse events occurred in 35.8% of ensartinib recipients versus 18.2% on placebo, with rash the most common severe event. The trial is funded by Betta Pharmaceuticals and registered as NCT05341583.
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