Roche's (SWX:ROG) Phase III ALINA study evaluating Alecensa (alectinib) has met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis, the company announced on Monday. The trial demonstrated a significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). This marks Alecensa as the first ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death for people with early-stage ALK-positive NSCLC in a Phase III trial.
The overall survival data from the study were immature at the time of this analysis, and no unexpected safety findings were observed. Roche plans to present the results from the ALINA study at an upcoming medical meeting and submit them to health authorities globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, commented on the results, "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." He further added that if approved, Alecensa could potentially treat cancer before it has spread, increasing chances of a cure.
Despite advancements in adjuvant chemotherapy, about half of all people with early lung cancer still experience a recurrence following surgery. Recent innovations, including immunotherapies, have improved outcomes for some patients with early-stage NSCLC. However, no approved ALK inhibitors exist for early-stage ALK-positive disease, which affects approximately five percent of people with NSCLC. This type of cancer is often found in younger individuals – typically 55 and under – who have a light or non-smoking history. Current guidelines recommend biomarker testing of resected surgical tissue or biopsy for ALK rearrangements in patients with stage IB to IIIA and IIIB NSCLC.
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