Approximately 5% of all non-small-cell lung cancers (NSCLC) are anaplastic lymphoma kinase-positive (ALK-positive). This study aims to compare the safety and efficacy of alectinib with crizotinib as the first-line treatment in patients with ALK-positive NSCLC.
This open-label, phase 3, randomized study included a total of 187 patients with ALK-positive NSCLC. The patients were randomly assigned in a 1:1 ratio to receive twice-daily oral alectinib (n=125) or crizotinib (n=62). The primary outcome of the study was progression-free survival (investigator-assessed). The safety of the two treatments was also analyzed.
During a median follow-up of 16.2 months in the alectinib group and 15.0 months in the crizotinib group, the investigator-led progression-free survival was significantly longer in the alectinib group (not estimable) compared with the crizotinib group (11.1 months). Progression-free survival (independent committee-assessed) was also longer in the alectinib group, as compared with the crizotinib group (hazard ratio 0.37). A total of 114 patients (91%) received an objective response with alectinib compared with 48 (77%) in crizotinib. Adverse events occurred less frequently in the alectinib group (29%), as compared with the crizotinib group (48%).
The research concluded that alectinib treatment in patients with ALK-positive NSCLC resulted in a longer progression-free survival with an acceptable safety profile.