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Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT)

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收录情况： ◇ SCIE

作者：
Shi Yuankai[1] ; Chen Jianhua[2] ; Zhang Helong[3] ; Zhang Zhihong[4] ; Zhang Yiping[5] ; Wang Zhehai[6] ; Zhang Shucai[7] ; Zhao Jian[8] ; Liu Chunling[9] ; Wang Xiuwen[10] ; Zhao Yanqiu[11] ; Hu Changlu[12] ; Yang Lei[13] ; Hao Xuezhi[1] ; Wang Lin[1] ; Liu Yunpeng[14] ; Yu Yan[15] ; Zhao Jun[16] ; Wang Mengzhao[17] ; Zhang Liangming[18] ; Sun Sanyuan[19] ; Hu Yanping[20] ; Gu Kangsheng[21] ; Hang Xiaosheng[22] ; Shan Jinlu[23] ; Zhang Yu[24] ; Tan Bangxian[25] ; Yang Weihua[26] ; Yang Runxiang[27] ; Si Meimei[28] ; Geng Huaize[28] ; Li Hui[28] ; Kang Xiaoyan[28] ;
机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China. [2]Thoracic Medicine Department I, Hunan Tumor Hospital, Changsha, China. [3]Oncology Department, the Second Affiliated Hospital of Air Force Medical University, Xi’an, China. [4]Department of Respiratory Oncology, Anhui Provincial Cancer Hospital, Hefei, China. [5]Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [6]Respiratory Medical Oncology Ward II, Shandong Provincial Institute of Cancer Prevention and Treatment, Jinan, China. [7]Oncology Department II, Beijing Chest Hospital, Capital Medical University, Beijing, China. [8]Thoracic Surgery I, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China. [9]Pulmonary Medicine Ward II, The Affiliated Tumour Hospital of Xingjiang Medical University, Urumqi, China. [10]Chemotherapy Department, Qilu Hospital of Shandong University, Jinan, China. [11]Respiratory Medicine Ward I, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China. [12]Ward IV of Department of Oncology, Anhui Provincial Cancer Hospital, Hefei, China. [13]Department of Respiratory Oncology, Gansu Province Cancer Hospital, Lanzhou, China. [14]Department of Medical Oncology Ward II, The First Hospital of China Medical University, Shenyang, China. [15]Respiratory Medicine Ward III, Harbin Medical University Cancer Hospital, Harbin, China. [16]Department of Thoracic Oncology I, Peking University Cancer Hospital, Beijing, China. [17]Department of Pulmonary and Critical care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. [18]Oncology Department, Yantai Yuhuangding Hospital, Yantai, China. [19]Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China. [20]Thoracic Oncology (2), Hubei Cancer Hospital, Wuhan, China. [21]Department of Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei, China. [22]Medical Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China. [23]Oncology Department, Army Medical Center of PLA, Chongqing, China. [24]Respiratory Department, Nanjing Chest Hospital, Medical School of Southeast University, Nanjing, China. [25]Department of Oncology, Affiliated Hospital of North Sichuan Medical college, Nanchong, China. [26]Department of Respiratory, Shanxi Provincial Cancer Hospital, Taiyuan, China. [27]The Second Department of Medical Oncology, Yunnan Cancer Hospital, Kunming, China. [28]Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
出处：
DOI： 10.1186/s12916-023-02738-5
ISSN：

摘要：
Iruplinalkib (WX-0593) is an anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor. Here we reported the single-arm, phase II study (INTELLECT) results of the efficacy and safety of iruplinalkib for ALK-positive crizotinib-resistant advanced non-small cell lung cancer (NSCLC) patients.ALK-positive crizotinib-resistant advanced NSCLC patients aged ≥18 years, with Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Patients received iruplinalkib 180 mg orally once daily for a 21-day cycle with a 7-day lead-in phase at 60 mg orally once daily. The primary endpoint was the independent review committee (IRC)-assessed objective response rate (ORR).From August 7, 2019, to October 30, 2020, 146 patients were included. As of the data cut-off date on November 30, 2021, the median follow-up time was 18.2 months (95% confidence interval [CI] 16.8-18.8). IRC-assessed ORR and disease control rate (DCR) were 69.9% (95% CI 61.7-77.2%) and 96.6% (95% CI 92.2-98.9%), respectively. Investigator-assessed ORR and DCR were 63.0% (95% CI 54.6-70.8%) and 94.5% (95% CI 89.5-97.6%), respectively. Investigator-assessed median duration of response and progression-free survival (the same as median time to progression) were 13.2 months (95% CI 10.4-17.7) and 14.5 months (95% CI 11.7-20.0), respectively. Corresponding IRC-assessed results were 14.4 months (95% CI 13.1-not evaluable [NE]), 19.8 months (95% CI 14.5-NE), and NE (95% CI 14.5-NE), respectively. Investigator-assessed intracranial ORRs were 46% (41/90, 95% CI 35-56%) in patients with central nervous system metastases and 64% (27/42, 95% CI 48-78%) in patients with measurable intracranial lesions. Overall survival data were immature. Treatment-related adverse events (TRAEs) occurred in 136/146 (93.2%) patients. The most common TRAEs were aspartate aminotransferase increased (63 [43.2%]), alanine aminotransferase increased (54 [37.0%]), and blood creatine phosphokinase increased (51 [34.9%]). Dose interruption, reduction, and discontinuation due to TRAEs occurred in 21 (14.4%), 16 (11.0%), and four (2.7%) patients, respectively.In this study, iruplinalkib (WX-0593) demonstrated favorable efficacy and manageable safety profiles in patients with ALK-positive crizotinib-resistant advanced NSCLC. Iruplinalkib could be a new treatment option for this patient population.Center for Drug Evaluation of National Medical Products Administration of China: CTR20190789, registered on April 28, 2019; ClinicalTrials.gov: NCT04641754, registered on November 24, 2020.© 2023. The Author(s).

基金：
This work was funded by Qilu Pharmaceutical Co., Ltd., Jinan, China and partly supported by China National Major Project for New Drug Innovation (2017ZX09304015).
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外文
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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Shi Yuankai,Chen Jianhua,Zhang Helong,et al.Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT)[J].BMC MEDICINE.2023,21(1):doi:10.1186/s12916-023-02738-5.
APA：
Shi Yuankai,Chen Jianhua,Zhang Helong,Zhang Zhihong,Zhang Yiping...&Kang Xiaoyan.(2023).Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT).BMC MEDICINE,21,(1)
MLA：
Shi Yuankai,et al."Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT)".BMC MEDICINE 21..1(2023)

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