Ensartinib in Resected ALK‑Positive Non‑Small‑Cell Lung Cancer

Cancer research · NSCLC · ALK

Among patients with completely resected stage IB to IIIB ALK‑positive NSCLC, the percentage of patients who were alive and disease‑free at 24 months was significantly higher with ensartinib than with placebo.

Background: ALK inhibitors are promising for resectable ALK‑positive NSCLC. We conducted a phase 3, double‑blind, randomized trial to compare ensartinib versus placebo in patients with completely resected, ALK‑positive stage IB‑IIIB NSCLC after adjuvant chemotherapy. Methods: 274 patients were randomized 1:1 to ensartinib 225 mg daily or placebo for 24 months. The primary endpoint was disease‑free survival (DFS) in stage II‑IIIB patients; the key secondary endpoint was DFS in the overall population. Results: At 24 months, 86.4% of stage II‑IIIB patients on ensartinib were alive and disease‑free versus 53.5% on placebo (HR 0.20, 95% CI 0.11–0.38, P<0.001). In the overall population, 87.3% versus 57.2% were alive and disease‑free (HR 0.20, 95% CI 0.10–0.37, P<0.001). Overall survival was immature. Grade ≥ 3 adverse events occurred in 35.8% of ensartinib recipients (rash most common) versus 18.2% on placebo. Conclusion: Ensartinib significantly improves DFS at 24 months compared with placebo in resected stage IB‑IIIB ALK‑positive NSCLC.

This study demonstrates that adjuvant ensartinib improves disease‑free survival in resected ALK‑positive NSCLC, providing a new therapeutic strategy for patients with this high‑risk disease.

Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.

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