FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer
Regulatory approval: On Dec 18, 2024, the FDA approved ensartinib (Ensacove) for adult patients with ALK-positive locally advanced or metastatic NSCLC who have not previously received an ALK inhibitor. Approval was supported by the phase 3 eXALT3 trial comparing ensartinib vs crizotinib, showing statistically significant improvement in blinded independent central review–assessed PFS (HR 0.56). No statistically significant overall survival difference was reported.
FDA approval (Dec 18, 2024): ensartinib for ALK+ advanced NSCLC
The US FDA approved ensartinib (Ensacove; Xcovery Holdings, Inc.) on Dec 18, 2024 for adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.
Supporting trial data
Efficacy and safety were evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial enrolling 290 patients with locally advanced or metastatic ALK-positive NSCLC without prior ALK-targeted therapy. Patients were randomized 1:1 to ensartinib or crizotinib.
- Primary endpoint: PFS by blinded independent central review
- HR 0.56 (95% CI, 0.40–0.79; p=0.0007)
- Median PFS: 25.8 months (95% CI, 21.8–NE) vs 12.7 months (95% CI, 9.2–16.6)
- Key secondary endpoint: OS
- No statistically significant difference: HR 0.88 (95% CI, 0.63–1.23; p=0.4570)
Safety and dosing (label highlights)
Most common adverse reactions (≥20%) were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue.
Recommended dose: 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.