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Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study

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作者：
Song Yuqin[1] * ; Malpica Luis[2] * ; Cai Qingqing[3] ; Zhao Weili[4] ; Zhou Keshu[5] ; Wu Jianqiu[6] ; Zhang Huilai[7] ; Mehta-Shah Neha[8] ; Ding Kaiyang[9] ; Liu Yao[10] ; Li Zengjun[11] ; Zhang Liling[12] ; Zheng Meifang[13] ; Jin Jie[14] ; Yang Haiyan[15] ; Shuang Yuerong[16] ; Yoon Dok Hyun[17] ; Gao Sujun[18] ; Li Wenyu[19] ; Zhai Zhimin[20] ; Zou Liqun[21] ; Xi Yaming[22] ; Koh Youngil[23] ; Li Fei[24] ; Prince Miles[25] ; Zhou Hui[26] ; Lin Lie[27] ; Liu Hui[28] ; Allen Pamela[29] ; Roncolato Fernando[30] ; Yang Zhenfan[31] ; Kim Won-Seog[32] ; Zhu Jun[33] ;
机构： [1]Peking University Cancer Hospital, Beijing, China. [2]The University of Texas MD Anderson Cancer Center, Houston, TX, USA. [3]Sun Yat-sen University Cancer Center, Guangzhou, China. [4]Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. [5]Henan Cancer Hospital, Zhengzhou, China. [6]Jiangsu Cancer Hospital-Jiangsu Institute of Cancer Research, Nanjing, China. [7]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [8]Washington University School of Medicine, St Louis, MO, USA. [9]Anhui Provincial Cancer Hospital, Hefei, China. [10]Chongqing Cancer Hospital, Chongqing, China. [11]Shandong First Medical University Affiliated Cancer Hospital, Jinan, China. [12]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. [13]Linyi Cancer Hospital, Linyi, China. [14]The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. [15]Zhejiang Cancer Hospital, Hangzhou Institute of Medicine, Chinese Academy of Sciences, Hangzhou, China. [16]Jiangxi Cancer Hospital, Nanchang, China. [17]Asan Medical Center, Seoul, South Korea. [18]The First Hospital of Jilin University, Changchun, China. [19]Guangdong Provincial People's Hospital, Guangzhou, China. [20]Hematologic Department, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. [21]West China Hospital, Sichuan University, Chengdu, China. [22]The First Hospital of Lanzhou University, Lanzhou, China. [23]Seoul National University Hospital, Seoul, South Korea. [24]The First Affiliated Hospital of Nanchang University, Nanchang, China. [25]Epworth Hospital, Melbourne, VIC, Australia. [26]Hunan Cancer Hospital, Changsha, China. [27]Hainan General Hospital, Haikou, China. [28]Beijing Hospital, Beijing, China. [29]Winship Cancer Institute of Emory University, Atlanta, GA, USA. [30]St George Hospital, Kogarah, NSW, Australia. [31]Dizal Pharmaceutical, Shanghai, China. [32]Samsung Medical Center, Seoul, South Korea. [33]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.
出处：
DOI： 10.1016/S1470-2045(23)00589-2
ISSN：

摘要：
Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, has shown encouraging anti-tumour activity in heavily pre-treated patients with relapsed or refractory peripheral T-cell lymphoma in a phase 1 study (JACKPOT8 Part A). Here, we report the full analysis of a phase 2 study, in which we assessed the anti-tumour activity of golidocitinib in a large multinational cohort of patients.We did a single-arm, multinational, phase 2 trial (JACKPOT8 Part B) in 49 centres in Australia, China, South Korea, and the USA. Eligible patients were adults (aged ≥18 years) with relapsed or refractory peripheral T-cell lymphoma who had received at least one previous line of systemic therapy and an Eastern Cooperative Oncology Group performance status of 0-2. Patients were given oral golidocitinib 150 mg once daily until disease progression or other discontinuation criteria were met. The primary endpoint was the CT-based objective response rate, assessed by an independent review committee (IRC) per Lugano 2014 classification. The activity analysis set included all patients who received at least one dose and whose pathological diagnosis of peripheral T-cell lymphoma had been retrospectively confirmed by a central laboratory and who had at least one measurable lesion at baseline assessed by IRC. The safety analysis set included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT04105010, and is closed to accrual and follow-up is ongoing.Between Feb 26, 2021, and Oct 12, 2022, we assessed 161 patients for eligibility, of whom 104 (65%) were enrolled and received at least one dose of study drug; the activity analysis set included 88 (85%) patients (median age 58 years [IQR 51-67], 57 [65%] of 88 were male, 31 [35%] were female, and 83 [94%] were Asian). As of data cutoff (Aug 31, 2023; median follow-up was 13·3 months [IQR 4·9-18·4]), per IRC assessment, the objective response rate was 44·3% (95% CI 33·7-55·3; 39 of 88 patients, p<0·0001), with 21 (24%) patients having a complete response and 18 (20%) having a partial response. In the safety analysis set, 61 (59%) of 104 patients had grade 3-4 drug-related treatment-emergent adverse events. The most common grade 3-4 drug-related treatment-emergent adverse events were neutrophil count decreased (30 [29%]), white blood cell count decreased (27 [26%]), lymphocyte count decreased (22 [21%]), and platelet count decreased (21 [20%]), which were clinically manageable and reversible. 25 (24%) patients had treatment-related serious adverse events. Deaths due to treatment-emergent adverse events occurred in three (3%) patients: two (2%) due to pneumonia (one case with fungal infection [related to golidocitinib] and another one with COVID-19 infection) and one (1%) due to confusional state.In this phase 2 study, golidocitinib showed a favourable benefit-risk profile in treating relapsed or refractory peripheral T-cell lymphoma. The results of this study warrant further randomised clinical studies to confirm activity and assess efficacy in this population.Dizal Pharmaceutical.Copyright © 2023 Elsevier Ltd. All rights reserved.

基金：
Dizal Pharmaceutical.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
第一作者：
第一作者机构： [1]Peking University Cancer Hospital, Beijing, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Song Yuqin,Malpica Luis,Cai Qingqing,et al.Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study[J].The Lancet. Oncology.2023,doi:10.1016/S1470-2045(23)00589-2.
APA：
Song Yuqin,Malpica Luis,Cai Qingqing,Zhao Weili,Zhou Keshu...&Zhu Jun.(2023).Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study.The Lancet. Oncology,,
MLA：
Song Yuqin,et al."Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study".The Lancet. Oncology .(2023)

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