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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, December 20, 2024
The U.S. Food and Drug Administration (FDA) recently approved the anaplastic lymphoma kinase (ALK) inhibitor ensartinib (Ensacove) for adults with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. For full prescribing information on ensartinib, visit Drugs@FDA.
Its efficacy was evaluated in eXALT3, an open-label, randomized, multicenter trial of 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients were randomly assigned 1:1 to receive ensartinib or the multitargeted tyrosine kinase inhibitor crizotinib.
The main efficacy outcome measure was progression-free survival, as evaluated by blinded independent central review. The key secondary efficacy outcome measure was overall survival. Ensartinib demonstrated a statistically significant progression-free survival improvement compared with crizotinib, with a hazard ratio (HR) of 0.56 (95% confidence interval [CI] = 0.40–0.79; P = .0007). With ensartinib, the median progression-free survival was 25.8 months (95% CI = 21.8 months to not estimable), and with crizotinib, it was 12.7 months (95% CI = 9.2–16.6 months). No statistically significant difference in overall survival was reported (HR = 0.88 [95% CI = 0.63–1.23], P = .4570).
The most common adverse reactions (≥ 20%) were rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.
The recommended dose of ensartinib is 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
U.S. Food and Drug Administration
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