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Phase 1/2 study of ceritinib in Chinese patients with advanced anaplastic lymphoma kinase-rearranged non–small cell lung cancer previously treated with crizotinib: Results from ASCEND-6

Lung Cancer Nov 09, 2020

Wu YL, Shi Y, Tan DSW, et al. - Inevitable relapse has been reported for patients with anaplastic lymphoma kinase-rearranged (ALK+) non–small cell lung cancer (NSCLC) treated with crizotinib, with the brain as a common site of progression. In ASCEND-6, a phase 1/2, single-arm study, ceritinib was evaluated in Chinese patients with advanced ALK+ NSCLC who were pretreated with crizotinib as the last therapy. A total of 103 patients were enrolled; of these, all received prior crizotinib, 70% received ≥ 1 prior chemotherapy regimen, and 63.1% had brain metastases at baseline. Ceritinib pharmacokinetics in this study were similar to that seen in ASCEND-1. Ceritinib was reported to have high response rate and durable clinical benefits. With a manageable safety profile, no new signals were identified. A positive benefit-to-risk ratio was reported for ceritinib in Chinese patients.

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