Ensartinib Approved for ALK-Positive Locally Advanced or Metastatic Non–Small Cell Lung Cancer
Expert Perspectives · Lyn Brook · 2024-12-26
The FDA has approved 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 received an ALK inhibitor.
Why Is the Approval of Ensartinib Important?
“Ensartinib, an oral tyrosine kinase inhibitor of ALK, has shown systemic and central nervous system efficacy for patients with ALK-positive NSCLC,” wrote Leora Horn, MD, Clinical Director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, and colleagues, in their published results of the eXalt3 trial (NCT02767804), on which approval was based.
Investigating Ensartinib in eXalt3
Efficacy was measured in the phase 3, open-label, active-controlled, multicenter trial which enrolled 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients were randomized 1:1 to receive either ensartinib or crizotinib.
The primary end point measured was progression-free survival, as evaluated by blinded independent central review (BICR). A key secondary end point measured was overall survival.
A statistically significant improvement was demonstrated by ensartinib when assessing progression-free survival. The median progression-free survival was 25.8 months in the ensartinib arm compared with 12.7 months in the crizotinib arm. No statistically significant difference was noticed in overall survival between the two.
Adverse Events
The most common adverse events experienced by ≥20% of those receiving ensartinib were rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.
Putting It Into Context
“In this randomized clinical trial, ensartinib showed superior efficacy to crizotinib in both systemic and intracranial disease. Ensartinib represents a new first-line option for patients with ALK-positive NSCLC,” concluded Dr. Horn and colleagues.
Dosing Instructions
The recommended dose of ensartinib is 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
For More Information
Ensacove™ (ensartinib) prescribing information (2024). Xcovery Holdings, Inc. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf
US Food and Drug Administration (2024). FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer