Novartis' Zykadia hits main goal of Phase III lung cancer study

Novartis announced Friday that a Phase III study of Zykadia (ceritinib) in patients with advanced ALK-positive non-small-cell lung cancer (NSCLC) met its primary endpoint, demonstrating a significant improvement in progression-free survival (PFS) versus standard chemotherapy, including maintenance.

The ASCEND-4 trial randomised 376 adults with Stage IIIB or IV ALK-positive NSCLC who had received no prior therapy for their advanced disease to receive Zykadia or pemetrexed-based platinum doublet chemotherapy, including pemetrexed maintenance. As well as the main goal of PFS, key secondary endpoints of the study included overall survival, overall response rate, duration of response, disease control rate and time to response.

Novartis noted along with an improvement in PFS, top-line data also showed clinically meaningful results for objective response rate and duration of response, while adverse events observed were consistent with the drug's previously known profile. The company indicated that full results from the study will be presented at an upcoming medical congress.

Zykadia was approved in Europe last year to treat adults with ALK-positive advanced NSCLC previously treated with Pfizer's Xalkori (crizotinib), and has also been cleared for the same indication in the US. Novartis said that it is "moving forward with global regulatory submissions" for the oral, selective ALK inhibitor based on data from the ASCEND-4 study.

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

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