EP1.01-62 The Safety Profile and Preliminary Efficacy of Ceritinib 450mg with Food in Chinese ALK/ROS-1 Positive NSCLC Patients

Ceritinib have shown potent efficacy in both ALK and ROS-1 rearranged NSCLC. However, high rate of treatment interruption was suffered due to gastrointestinal or liver toxicity using Ceritinib 750mg fasting in previous study. Recently, ASCEND-8 study reported an improved tolerance and a trend to better efficacy with 450mg with food, but little data is available in Chinese patients. This first-time real-world study aims to assess the safety profile and preliminary efficacy of Ceritinib 450mg with food in Chinese patients. From Oct 2018 to March 2019, 51 ALK or ROS1 positive NSCLC patients received ceritinib were enrolled from 8 centers in Sichuan province. Safety profile and preliminary efficacy were retrospectively analyzed. The follow-up was to 31st March 2019. The baseline characteristics of enrolled patients are listed in Table 1. The median time from diagnosis to Ceritinib treatment is 15.93 months（Range：1.37- 89.97), the median treatment duration is 2.63 months （Range：0.2-5.73）by the time of data cut off. 50 out of 51 patients were assessable for toxicity. The adverse event (AE) rate is 76%, majority of which are grade 1/2. Only 2 patients reduced to 300mg due to AE and no patient dead or terminated treatment due to Ceritinib related AEs. Details are in the Table 2. By the data cut-off, 15 patients have stopped treatment due to disease progression (33.3%), death (53.3%) or other reasons (13.3%). Among the 39 patients underwent radiological assessment, the ORR was 41.0% and DCR was 87.2%.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Ceritinib 450mg with food demonstrated a good safety profile and efficacy with lower AE incidence rate and better compliance rate compare to ASCEND-8 data for Chinese patients in real-world setting.