In patients with completely resected stage IB to IIIB ALK-positive non-small cell lung cancer, ensartinib significantly increased the percentage of patients alive and disease-free at 24 months compared to placebo, with an 80% reduction in the risk of recurrence or death. The safety profile was consistent with previous reports, and no new safety signals were identified.
Study
|
Phase 3, double-blind, randomized trial [ELEVATE, NCT05341583] |
| Completely resected, ALK-positive stage IB to IIIB NSCLC after adjuvant chemotherapy |
| Ensartinib (n=137) vs placebo (n=137) for 24 months
|
Efficacy
|
24-mo DFS (stage II-IIIB NSCLC): 86.4% vs 53.5% (HR 0.20 [0.11-0.38]) |
| 24-mo DFS (overall population): 87.3% vs 57.2% (HR 0.20 [0.10-0.37]) |
| CNS DFS: (HR 0.22 [0.08-0.60]) |
| OS data immature
|
Safety
|
Grade >=3 AE: rash (14.6% vs 0%), edema (2.9% vs 0%), respiratory tract infection (2.9% vs 0.7%), infectious pneumonia (5.1% vs Not reported) |
| Serious AE: 18.2% vs 10.2% |
| Treatment discontinuations due to AE: 2.2% vs 1.5%
|
N Engl J Med 2026;395:151-61
Yue D, Huang M, Song P Ensartinib in Resected ALK-Positive Non–Small-Cell Lung Cancer
http://doi.org/10.1056/NEJMoa2518990
Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026
