Results from the phase 3 ELEVATE trial show that ensartinib (Ensacove) significantly reduced the risk of cancer recurrence in patients with completely resected stage IB to IIIB ALK-positive non-small cell lung cancer (NSCLC) after chemotherapy.
Among patients with stage II to IIIB disease, the 24-month disease-free survival (DFS) rate was 86.4% with ensartinib, compared with 53.5% with placebo. In the overall study population, the 24-month DFS rate was 87.3% versus 57.2%, respectively. Median DFS had not yet been reached for the ensartinib group, while it was 24.8 months for the placebo group.
Serious side effects (grade 3 or higher) occurred in 35.8% of patients receiving ensartinib, compared with 18.2% of those receiving placebo. No treatment-related deaths were reported.
The phase 3 trial enrolled patients from multiple centers and randomly assigned them to receive either oral ensartinib or placebo daily for up to 24 months.
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