In this article
On December 18, 2024, the Food and Drug Administration sanctioned ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor.
The efficacy was assessed in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial involving 290 patients with locally progressed or metastatic ALK-positive NSCLC who had not previously undergone ALK-targeted treatment. Patients were randomized in a 1:1 ratio to receive either ensartinib or crizotinib.
The primary effectiveness endpoint was progression-free survival (PFS) assessed by blinded independent central review. The primary secondary efficacy outcome measure was overall survival (OS). Ensartinib exhibited a statistically significant enhancement in progression-free survival (PFS) vs to crizotinib, with a hazard ratio (HR) of 0.56 (95% CI: 0.40, 0.79; p-value 0.0007).
The median progression-free survival (PFS) was 25.8 months (95% confidence interval: 21.8, not estimable) in the ensartinib group and 12.7 months (95% confidence interval: 9.2, 16.6) in the crizotinib group. No statistically significant change in overall survival was observed (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570).
The predominant adverse responses (≥20%) included rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and exhaustion.
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About Sai Sree
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