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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.

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机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China [2]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [3]National Cancer Center Singapore, Singapore [4]Cancer Center, 307 Hospital of the Academy of Military Medical Sciences, Beijing, China [5]Jilin Province Cancer Hospital, Changchun, China [6]The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China [7]Beijing Cancer Hospital, Beijing, China [8]West China Hospital, Sichuan University, Chengdu, China [9]Xinqiao Hospital, Third Military Medical University, Chongqing, China [10]Shanghai Respiratory Research Institute, Shanghai, China [11]Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA [12]Beijing Novartis Pharma Co., Ltd, Beijing, China [13]Sun Yat-Sen University Cancer Center, Guangzhou, China

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Patients with anaplastic lymphoma kinase-rearranged (ALK+) non-small cell lung cancer (NSCLC) treated with crizotinib inevitably relapse, with brain as common site of progression. ASCEND-6, a phase 1/2, single-arm study, included adult Chinese patients with stage IIIB or IV ALK+ NSCLC pretreated with crizotinib as the last therapy (irrespective of prior chemotherapies [≤2]). Primary endpoints were pharmacokinetics (PK), safety, and tolerability. Key secondary endpoint was overall response rate (ORR; investigator assessed). Of the 103 enrolled patients, all received prior crizotinib, 70 % received ≥1 prior chemotherapy regimen, and 63.1 % had brain metastases at baseline. In the phase 1 component, 20 patients completed a 5-day PK run-in period. Median Tmax (n = 16) was ∼6 h; geometric means of AUC0-24 h (n = 16) and Cmax (n = 16) at steady state were 22,000 ng*h/mL and 1080 ng/mL, respectively. In the final analysis, median follow-up time was 34 months (range: 27.8-40.6). The ORR was 41.7 % (95 % confidence interval [CI]: 32.1-51.9), and median progression-free survival was 7.2 months (95 % CI: 4.1-7.5). Median overall survival was 17.5 months (95 % CI: 10.8-24.3). Most frequent adverse events, regardless of study drug relationship (mostly grade 1/2), were diarrhea (74.8 %), vomiting (62.1 %), alanine transaminase increased (59.2 %), aspartate transaminase increased (58.3 %), and nausea (58.3 %). Ceritinib PK in Chinese patients is consistent with those observed in the global ASCEND-1 study. Ceritinib was well tolerated and showed durable responses in Chinese patients with ALK+ NSCLC who progressed after crizotinib and ≤2 prior lines of chemotherapy. Copyright © 2020. Published by Elsevier B.V.

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大类 | 2 区医学

小类 | 2 区肿瘤学 2 区呼吸系统

最新[2023]版：

大类 | 2 区医学

小类 | 3 区肿瘤学 3 区呼吸系统

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出版当年[2020]版：

Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 4.5 最新[2023版] 4.7 最新五年平均 5.705 出版当年[2020版] 5.602 出版当年五年平均 4.702 出版前一年[2019版] 6.081 出版后一年[2021版]

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第一作者机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China [*1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.

通讯作者：

通讯机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China [*1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.

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