Roche’s alectinib superior to crizotinib

Announcing headline results from the global Phase III ALEX study, Roche said that Alecensa (alectinib) was superior in terms of progression-free survival to crizotinib, the current standard of care for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer in advanced stage. Roche said concrete figures will be presented at an upcoming meeting and that it will file globally for market authorisation of Alecensa as first-line treatment. In the US, the oral drug was granted Breakthrough Therapy designation in 2016.

Superiority of aceltinib to crizotinib in terms of PFS had been shown previously in Japanese patients. The open-label Phase III study enrolled about 300 patients, who were randomised 1 to 1.  “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.

The ALEX study is part of the company’s commitment to convert the current conditional approval of Alecensa in Europe for crizotinib-refractive patients with ALK-positive, metastatic NSCLC to a full approval as an initial treatment.