Roche’s randomised phase III ALEX study 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, Roche said. The safety profile of Alecensa was consistent with that observed in previous studies, with no new or unexpected adverse events.
Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development said:“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.”
The United States Food and Drug Administration (FDA) in September 2016 granted Alecensa Breakthrough Therapy Designation (BTD) for the treatment of people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.
Alecensa is approved as a monotherapy (alone) for people with ALK-positive NSCLC who have progressed or are intolerant to crizotinib in Europe, the U.S. and nine other countries globally, the company said. The drug is also approved in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). In the US, 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.
In the European Union, Alecensa was granted conditional marketing authorisation in February 2017 for the monotherapy treatment of people with ALK-positive NSCLC previously treated with crizotinib. The ALEX study is also acts as the post-authorisation safety study to meet the specific obligation study to convert the conditional approval into a full approval in the EU for people with ALK-positive, advanced NSCLC previously treated with crizotinib, the company said.