Roche has presented late-stage data showing that its Alecensa was superior to Pfizer’s Xalkori on progression-free survival in patients with a specific type of lung cancer.
The global, randomised Phase III ALEX study hit its primary endpoint in showing that Alecensa (alectinib) as a first-line treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) versus Xalkori (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 Roche’s drug was better than Pfizer’s as an initial treatment in this type of lung cancer, the Swiss drug giant noted, adding that its safety profile was also consistent with that observed in previous studies.
Specific data weren’t released but are to be presented at an upcoming medical meeting and will also be submitted to global health authorities with a view to expanding the scope of Alecensa, which was first approved in 2015 to treat patients with advanced ALK-positive NSCLC who have failed on Xalkori.
“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.”
Around 75,000 people globally are diagnosed with ALK-positive NSCLC every year.