Genentech’s Alecensa superior to crizotinib in certain Lung Cancer: study

Genentech, a member of the Roche Group, has announced that the global, randomized Phase III ALEX study met its primary endpoint and showed that Alecensa (alectinib) as an initial (first-line) treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to crizotinib in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This is the second Phase III trial to show that Alecensa was superior as an initial treatment compared to crizotinib in this type of lung cancer.

"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, chief medical officer and head of Global Product Development. "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."

Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.