Clinical takeaway
Adjuvant ensartinib substantially improved disease-free survival; overall survival remains immature and longer follow-up is required.
Trial at a glance
- 274 patients with stage IB (at least 4 cm) to IIIA ALK-positive NSCLC.
- Ensartinib 225 mg once daily versus placebo for up to 24 months.
- Primary endpoint: disease-free survival in stage II-IIIB disease.
Key results
- 24-month DFS in the primary population: 86.4% with ensartinib versus 53.5% with placebo; HR 0.20 (95% CI 0.11-0.38).
- Overall randomized population: 87.3% versus 57.2%; HR 0.20 (95% CI 0.10-0.37).
- Grade 3 or higher adverse events occurred in 35.8% versus 18.2%; rash was the most common grade 3 or higher event.
What this means for practice
Test resected NSCLC for ALK rearrangements, discuss adjuvant therapy in appropriate patients, monitor treatment-related adverse events, and continue surveillance while mature survival data are awaited.
References
- ELEVATE Trial. N Engl J Med. 2026; online July 8, 2026.
- ClinicalTrials.gov: NCT05341583.
Educational summary from Medeasy Review Issue 01. Verify recommendations against current guidelines, local approvals, product information, and the individual patient's circumstances.
