This article is more than 5 years old. Information may no longer be current.
Alectinib extends PFS in advanced ALK–positive NSCLC
Click Here to Manage Email Alerts
A phase 3 study designed to evaluate alectinib in patients with anaplastic lymphoma kinase–positive advanced non–small cell lung cancer met its primary endpoint of improved PFS, according to the drug’s manufacturer.
The randomized, multicenter, open-label ALUR study evaluated the safety and efficacy of alectinib (Alecensa, Genentech) compared with chemotherapy in 119 patients with ALK–positive NSCLC who previously underwent one line of platinum-based chemotherapy and crizotinib (Xalkori, Pfizer).
PFS served as the primary endpoint. Secondary endpoints included OS and central nervous system objective response rate in patients with measurable brain metastases, at baseline and median time to central nervous system progression.
“We are pleased to announce that the results of the phase 3 ALUR trial further support the use of Alecensa as a treatment for people with ALK–positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options,” Sandra Horning, MD, chief medical officer and head of global product development for Roche/Genentech, said in a company-issued press release. “The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster.”
Peer-reviewed data will be published later this year.
The FDA previously approved alectinib monotherapy to treat patients with ALK-positive NSCLC whose disease worsened after or who could not tolerate treatment with crizotinib.
The agent also is being evaluated in the phase 3 ALEX study, designed to compare alectinib with crizotinib as first-line treatment for ALK–positive NSCLC. Data are expected to be released this year.