Positive results from ASCEND-1 study for Zykadia in ALK+ Non Small Cell Lung Cancer - Novartis

Novartis announced new data, from ASCEND-1 study, showing patients with anaplastic lymphoma kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) lived an average of more than 18 months without their cancer progressing when taking Zykadia (ceritinib) as their first ALK inhibitor. Overall, data from the pivotal study confirmed ceritinib continues to demonstrate efficacy in ALK+ NSCLC patients regardless of whether or not they received previous treatment with an ALK inhibitor. In addition, patients who entered the study with brain metastases experienced similar results following treatment with ceritinib. These data are being presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid.

Among the combined study population of 246 NSCLC patients, including patients who had received previous treatment with an ALK inhibitor as well as those receiving one for the first time, ceritinib achieved an overall response rate (ORR) of 61.8% and a median progression-free survival (PFS) of 9.0 months. In the subset of 83 patients who had not received prior treatment with an ALK inhibitor, ceritinib achieved an ORR of 72.3% and a median PFS of 18.4 months. Among the subset of 163 patients who were previously treated with the commonly prescribed ALK inhibitor crizotinib, the ORR was 56.4% and the median PFS was 6.9 months.