Lung Cancer Drug Shows Superiority in Phase 3 Trial
Alecensa found superior to crizotinib in advanced or recurrent, ALK-positive non-small cell lung cancer.
An open-label, randomized phase 3 study found that alectinib (Alecensa) showed superior efficacy over crizotinib in people with advanced ALK-positive non-small cell lung cancer (NSCLC).
Alecensa is an oral anaplastic lymphoma kinase (ALK) inhibitor used to reduce the risk of disease progression and improve progression-free survival (PFS).
The purpose of the J-ALEX phase 3 study compared the efficacy and safety of Alecensa to crizotinib in patients in Japan. There was 207 people enrolled with ALK-positive, advanced or recurrent NSCLC, who were not treated previously with an ALK inhibitor.
Participants were randomized to receive Alecensa or crizotinib in one-to-one ratio groups. The results of the study found that Alecensa reduced the risk of disease worsening or death by 66% compared with crizotinib (HR=0.34, 99 percent CI: 0.17-0.70, p<0.0001).
In the Alecensa arm, the median PFS was not reached (95% CI: 20.3 months-not reached) compared with 10.2 median PFS (95% CI: 8.2-12.0) in the crizotinib arm.
There were fewer grade 3-4 adverse events (AE) in the Alecensa group versus the crizotinib group (51% versus 27%, respectively).
The most common AE (>30% frequency) found in patients taking Alecensa was constipation, while the most common AEs for crizotinib was nausea, diarrhea, vomiting, visual disturbance, alteration in dysgeusia, constipation, an elevation in alanine transaminase (ALT), and aspartate transaminase (AST).
“This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We believe these efficacy and safety results represent a clinically meaningful advancement for people with ALK-positive lung cancer, and we plan to discuss these data with health authorities, including the FDA.”
The FDA granted accelerated approval for Alecensa in December 2015 for the treatment of patients with ALK-positive NSCLC who progressed with, or are intolerant to, crizotinib.
The official data from the J-ALEX clinical study will be presented on June 6, 2016 at the American Society of Clinical Oncology (ASCO) annual meeting.