Roche's lung cancer drug beats Pfizer rival in study
Roche has announced that its drug Alecensa (alectinib) succeeded in meeting its primary endpoint in a Phase 3 trial assessing its efficacy as a first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.
Alecensa was already approved in 2015 for the treatment of ALK-positive NSCLC as an option in those patients where Pfizer’s Xalkori (crizotinib) had proved ineffective, but now the drug has proven its efficacy against its rival as a head-to-head treatment. The 303-participant trial showed that Alecensa “significantly reduced” progression-free survival (PFS) compared to 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, CMO 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.”
The study kills two birds with one stone for Roche, as it also provides the post-authorisation data necessary to secure full approval from the drug’s existing conditional approval in the EU.
The company now plans to submit the new data to health authorities including the FDA, will full results to be revealed at an upcoming medical event.