Updated on 27 May 2016
Globally located pharmaceutical company Roche has announced that Alecensa, an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC).
"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."
Alecensa was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.
ALEX, a global, randomised Phase III study, is ongoing, comparing Alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumours were characterised as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. This study is part of the company's commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.