Successful Phase III ASCEND-4 trial for Zykadia (ceritinib)for ALK+ non small cell lung cancer patients.-Novartis

Novartis has announced top-line results from its Phase III ASCEND-4 clinical study for Zykadia (ceritinib) in patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). The multicenter, randomized trial (NCT01828099), which assessed the efficacy and safety of Zykadia in previously untreated adult patients, met its primary endpoint, demonstrating clinically significant improvement in progression free survival (PFS) compared to standard chemotherapy, including maintenance.

In addition to PFS, clinically meaningful results were achieved across key secondary efficacy measures, including objective response rate (ORR) and duration of response (DoR). The adverse events observed were consistent with the previously known adverse event profile of Zykadia. A full analysis of ASCEND-4 data along with detailed efficacy and safety results will be submitted for presentation at a major medical congress.