Alecensa is a kinase inhibitor for the treatment of ALK-positive, metastatic non-small cell lung cancer.
Alectinib (Alecensa) demonstrated superiority over crizotinib by reducing the risk of disease progression or death by more than 50% in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Alectinib is a kinase inhibitor approved under accelerated approval for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib, according to a press release.
For the randomized, multicenter, open-label phase 3 ALEX study, investigators evaluated the safety and efficacy of alectinib compared with crizotinib in treatment-naive patients. The study was conducted in 303 individuals across 161 sites in 31 countries.
The primary endpoint is progression-free survival (PFS) and secondary endpoints are independent review committee (IRC)-assessed PFS, time to central nervous system (CNS) progression, objective response rate, duration of response, overall survival, health-related quality of life, and safety.
The results of the study showed that alectinib reduced the risk of disease worsening or death by 53% compared with crizotinib. IRC-reported median PFS was not yet reached in the alectinib arm versus 11.1 months in the crizotinib arm, according to the release.
The IRC-reported median PFS was 25.7 months among patients in the alectinib arm compared with 10.4 months in the crizotinib arm. The risk of CNS progression was reduced by 84% in the alectinib arm.
The 12-month cumulative rate of CNS progression for patients with or without existing CNS metastases of baseline was 9.4% among patients in the alectinib arm and 41.4% for patients in the crizotinib arm, according to the release.
Currently, the overall survival data is considered immature, with only about a quarter of events being reported.
The most common grade 3 to 5 adverse events (AEs) were increased liver enzymes and anemia. AEs that resulted in discontinuation, dose reduction, and dose interruption were lower in the alectinib arm compared with the crizotinib arm.
“Alecensa reduced the risk of disease progression by more than half and reduced the risk of cancer spreading to or growing in the brain, which can have devastating effects for patients,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a release. “These results significantly improve upon the standard of care for this disease, extending the average time that people lived without their disease worsening from less than a year to more than 2 years. We are submitting these data to regulatory authorities around the world.”
Findings from the ALEX study were presented at the American Society of Clinical Oncology annual meeting in Chicago, and simultaneously published in the New England Journal of Medicine.