Second phase 3 study meets primary endpoint in improving lung cancer survival.
A phase 3 study met its primary endpoint of progression-free survival (PFS), demonstrating that first-line treatment with alectinib (Alecensa) significantly reduced the risk of death or disease compared with crizotinib in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
The multicenter, open-label, randomized phase 3 ALEX study evaluated the safety and efficacy of alectinib versus crizotinib in treatment-naïve patients with ALK-positive NSCLC, according to a press release.
The participants were randomized to receive either alectinib or crizotinib. The primary endpoint of the study is PFS, as assessed by the independent review committee. Secondary endpoints included PFS, time to central nervous system progression, objective response rate, duration of response, overall survival, health-related quality of life, and safety.
The study was conducted in 303 patients across 161 sites in 31 countries, according to the release.
“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 a 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.”
Full data from the study will be presented at an upcoming medical meeting and submitted to global health authorities, including the FDA.
In September 2016, the FDA granted alectinib Breakthrough Therapy Designation for the treatment of individuals with advanced ALK-positive NSCLC who were treatment naive.