Patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) live significantly longer without disease progression when treated with a new drug compared with those treated with crizotinib.
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ALK-positive NSCLC is commonly diagnosed in younger patients (median age: 52), in women, and in those with a light or non-smoking history. Alecensa (alectinib, Genentech) is a kinase inhibitor approved by the US Food and Drug Administration (FDA) in treating patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to first-line crizotinib.
Researchers from Genentech conducted a randomized, multicenter, open-label phase III trial to evaluate the efficacy and safety of alectinib compared with crizotinib as first-line therapy for ALK-positive NSCLC. A total of 303 patients were randomized (1:1) to receive either alectinib or crizotinib. The primary endpoint of the study was progression-free survival (PFS) and secondary endpoints included time to central nervous system progression, objective response rate, duration of response, overall survival, health-related quality of life, and safety.
Results of the study showed that alectinib significantly improved PFS, reducing the risk of disease worsening or death. This is the second phase III trial that has reported alectinib as a superior initial treatment compared with crizotinib for patients with ALK-positive NSCLC. Results of the study were made public in a press release by Genentech (April 9, 2017). Data will be submitted to the FDA and presented at an upcoming medical meeting.
“Our goal is to transform the standard of care and we are excited to share these results with the lung cancer community,” said Sandra Horning, MD, chief medical officer, head of Global Product Development, Genentech. “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.”
Adverse events associated with alectinib include hepatotoxicity, inflammation of the lungs, bradycardia, myalgia, tiredness, constipation, and swelling. – Zachary Bessette
