Primary Endpoint Met in Alecensa Study: Roche

Roche says recent data from its Phase 3 ALINA study evaluating Alecensa (alectinib) compared with platinum-based chemotherapy met its primary endpoint of disease-free survival (DFS) in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The data, which was unveiled during a prespecified interim analysis, also shows that Alecensa demonstrated a “statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage 1B (tumor greater than 4cm) to 3A ALK)-positive NSCLC,” according to the company. It notes that overall survival data were “immature” when the analysis took place.

Alecensa is currently FDA-approved as an initial (first-line) treatment for ALK-positive, metastatic NSCLC. Roche says the latest results will be presented at an upcoming medical meeting and submitted to the agency to support expanded approval.