A global phase 3 study has met its primary endpoint, demonstrating that alectinib (Alecensa, Genentech/Roche) as a first-line treatment significantly reduced the risk of disease-worsening or death compared with crizotinib (Zalkori, Pfizer Oncology/EMD Serono) in patients with anaplastic lymphoma kinase (ALK)-positive advanced non–small-cell lung cancer (NSCLC). This is the second late-stage trial to show that alectinib was superior as an initial treatment compared with crizotinib in this type of lung cancer.
The ALEX trial was a randomized, multicenter, open-label study evaluating the efficacy and safety of alectinib compared with that of crizotinib in treatment-naïve patients with ALK-positive NSCLC whose tumors were characterized as ALK-positive by the Ventana ALK (D5F3) CDx immunohistochemistry assay (Roche Tissue Diagnostics). A total of 303 patients in 31 countries were randomly assigned to receive either alectinib or crizotinib. The trial’s primary endpoint was investigator-assessed progression-free survival, and secondary endpoints included independent review committee-assessed PFS; the time to central nervous system progression; the objective response rate; the duration of response; overall survival; health-related quality of life; and safety.
In the United States, alectinib is approved as monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant of crizotinib. The medication was granted accelerated approval by the FDA in December 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant of crizotinib. The ALEX trial was part of Roche’s effort to convert the current accelerated approval of alectinib in patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant of crizotinib to a full approval as an initial treatment.
ALK-positive NSCLC often occurs in younger people who have a history of light or no smoking history. It is almost always found in patients with adenocarcinoma, a type of NSCLC.
Source: Roche; April 10, 2017.