BASEL (dpa-AFX) - Novartis (NVS) announced top-line results from its Phase III ASCEND-4 clinical study for Zykadia (ceritinib) in patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. The trial, 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 compared to standard chemotherapy, including maintenance.
The company said clinically meaningful results were achieved across key secondary efficacy measures, including objective response rate and duration of response. The adverse events observed were consistent with the previously known adverse event profile of Zykadia.
Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology, stated: 'We are pleased to see these topline results show promise in untreated patients with advanced disease, and look forward to sharing these data with regulatory authorities in the coming months.'
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