Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC cases.
Primary Endpoint Met and Implications for Disease-Free Survival
According to the press release, the study successfully met its primary endpoint, demonstrating a significant and meaningful improvement in disease-free survival (DFS). This achievement marks Roche’s Alecensa as the first ALK inhibitor with Phase III data showing a reduction in the risk of disease recurrence or death for patients with ALK-mutated NSCLC.
Alecensa’s Global Approval and Regulatory Filings for Early-Stage NSCLC
Alecensa is already approved in over 100 markets as a first-line treatment against metastatic NSCLC with ALK mutations. The new results from the trial will be instrumental in supporting regulatory filings for the use of Alecensa in early-stage ALK-positive NSCLC worldwide, potentially expanding the treatment options for patients and reinforcing Roche’s leadership in targeted cancer therapies.-Fineline Info & Tech
