First-line alectinib extends PFS for patients with ALK–positive NSCLC
First-line treatment with alectinib extended PFS compared with crizotinib among patients with anaplastic lymphoma kinase–positive advanced non–small cell lung cancer, according to results of a phase 3 trial.
Alectinib (Alecensa, Genentech) — a kinase inhibitor — received accelerated approval in December 2015 for treatment of patients with ALK–positive metastatic NSCLC who progressed on or are intolerant to crizotinib (Xalkori, Pfizer).
The multicenter, randomized phase 3 ALEX study compared alectinib with crizotinib as initial treatment for ALK–positive NSCLC.
The analysis included 303 patients randomly assigned 1:1 to alectinib or crizotinib. PFS served as the primary endpoint. Secondary endpoints included independent review committee–assessed PFS, time to central nervous system progression, objective response rate, duration of response, OS, health-related quality of life and safety.
Alectinib-treated patients achieved superior PFS. The drug’s safety profile appeared consistent with that observed in previous studies, and no new or unexpected adverse events occurred. The most common side effects reported with the drug include tiredness, constipation, and swelling in the hands, feet, ankles and eyelids.
Complete results of the ALEX study will be presented at an upcoming medical meeting, according to a Genentech-issued press release.
This is the second phase 3 trial to show superior efficacy with alectinib compared with crizotinib as initial treatment for ALK–positive NSCLC.
In September, the FDA granted breakthrough therapy designation to alectinib for the treatment of patients with advanced ALK–positive NSCLC who have not received prior treatment with an ALK inhibitor.
“Our goal is to transform the standard of care, and we are excited to share these results with the lung cancer community,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the press release. “As part of its breakthrough therapy designation, we hope to bring Alecensa as an initial treatment for people with ALK–positive NSCLC as soon as possible and will discuss these data with global health authorities.”