Biotechnology company Genentech, part of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), said on Friday that its Phase III ALINA trial, evaluating Alecensa (alectinib) against platinum-based chemotherapy, has achieved its primary endpoint of disease-free survival (DFS) in an interim analysis.

The study demonstrated a statistically significant and clinically meaningful improvement in DFS when used as adjuvant therapy for individuals with completely resected Stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Alecensa is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death in a Phase III trial for early-stage ALK-positive NSCLC.

While overall survival (OS) data remain preliminary, no unexpected safety findings were detected. The results will be presented at an upcoming medical meeting and submitted to global health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech.