Ensartinib (Ensacove; Xcovery Holdings, Inc) has been approved for use in treating adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.1
Researchers evaluated the treatment’s efficacy in eXALT3 (NCT02767804), an open-label, active-controlled, multicenter trial in 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy who were randomly assigned 1:1 to receive either ensartinib or crizotinib.
Ensartinib demonstrated a statistically significant progression-free survival (PFS) improvement when compared with crizotinib with a hazard ratio of 0.56 (95% confidence interval [CI], 0.40-0.79; P=.0007). The median PFS was 25.8 months (95% CI, 21.8-not estimable) in the ensartinib arm compared with 12.7 months (95% CI, 9.2-16.6) in the crizotinib arm.
The most common adverse reactions were rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.
Reference
- FDA. FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer. December 18, 2024. Accessed February 10, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer