Genentech announced positive results from its Phase 3 trial of Alecensa (alectinib) in individuals with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The randomized, multi-center, open-label study, ‘ALEX’, evaluated the efficacy and safety of alectinib vs. crizotinib in 303 treatment-naïve individuals with ALK-positive NSCLC. Participants in the trial were randomized (1:1) to receive either alectinib or crizotinib. The primary endpoint was progression-free survival (PFS); secondary endpoints included independent review committee (IRC)-assessed PFS, time to central nervous system (CNS) progression, objective response rate (ORR), duration of response, overall survival, health-related quality of life (HRQoL) and safety. 

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Results from the study met its primary endpoint of significant improvement in progression-free survival among the alectinib-treated group compared to the crizotinib group.

Alecensa was granted accelerated approval by the Food and Drug Administration (FDA) in 2015, as a treatment for ALK-positive NSCLC in patients who have progressed on or are intolerant to crizotinib. The ALEX study is intended to convert Alecensa to full approval as an initial treatment. Full data from the ALEX trial will be presented at a upcoming medical meeting. 

Alecensa, a kinase inhibitor, is available as 150mg strength capsules in 240-count bottles.

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