个人中心| | 帮助
高级检索
当前位置： 首页 > 详情页

Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).

| 认领 | 导出 | |

文献详情

资源类型：
WOS体系：
Pubmed体系：

收录情况： ◇ SCIE

作者：
Shi Yuankai[1] ; Wu Jianqiu[2] ; Wang Zhen[3] ; Zhang Liling[4] ; Wang Zhao[5] ; Zhang Mingzhi[6] ; Cen Hong[7] ; Peng Zhigang[8] ; Li Yufu[9] ; Fan Lei[10] ; Guo Ye[11] ; Ma Liping[12] ; Cui Jie[13] ; Gao Yuhuan[14] ; Yang Haiyan[15] ; Zhang Hongyu[16] ; Wang Lin[17] ; Zhang Weihua[18] ; Zhang Huilai[19] ; Xie Liping[20] ; Jiang Ming[21] ; Zhou Hui[22] ; Shuang Yuerong[23] ; Su Hang[24] ; Ke Xiaoyan[25] ; Jin Chuan[26] ; Du Xin[27] ; Du Xin[28] ; Liu Li[29] ; Xi Yaming[30] ; Ge Zheng[31] ; Feng Ru[32] ; Zhang Yang[33] ; Zhou Shengyu[1] ; Xie Fan[34] ; Wang Qian[34] ;
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]Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China. [3]Department of Oncology, Linyi Cancer Hospital, Linyi, China. [4]Department of Lymphoma, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [5]Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. [6]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [7]Department of Hematology, Lymphoma and Pediatric Oncology, Guangxi Medical University Affiliated Tumor Hospital and Oncology Medical College, Nanning, China. [8]Department of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [9]Department of Hematology, Henan Cancer Hospital, Zhengzhou, China. [10]Department of Hematology, Jiangsu Province Hospital, Nanjing, China. [11]Department of Oncology, Shanghai East Hospital, Shanghai, China. [12]Department of Hematology, Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, China. [13]Department of Hematology, Gansu Provincial Cancer Hospital, Lanzhou, China. [14]Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [15]Department of Lymphoma, Zhejiang Cancer
出处：
DOI： 10.1186/s13045-021-01033-1
ISSN：

关键词： Immunotherapy PD-1 inhibitor T cell lymphomas

摘要：
Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients. We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria. Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30-22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2-51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related. In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population. This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.

基金：
This study was funded by Genor Biopharma Co., Ltd., China. Special thanks to the following key members: Dr. Joe Zhou, Dr. Yu Wang (consulting), Huiyang Cheng, Dr. Haige Shen (consulting), Shengbin Ren, Dr. Yue Kang, Dr. Tong Li, Dr. Chao Gao, Dr. Xifang Liu, Yi Zheng, Xuexiang Zhang, Ming Tong, Chunyan Yuan, Gaijing Xue, Cuncun Li, Jing Zhang, Jie Guo, Dr. Ziyi Kan, Zhen Gao, Jun Lin, Ke Tan, and Hongbin Yan. Authors also appreciate the contributions from all the investigators, the patients and their families. Finally, authors thank Shiyu Jiang (Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University) for her medical writing assistance, funded by Genor Biopharma Co., Ltd., China.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 血液学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 血液学 1 区 肿瘤学
JCR分区：
出版当年[2021]版：
Q1 HEMATOLOGY Q1 ONCOLOGY
最新[2023]版：
Q1 HEMATOLOGY Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[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,Wu Jianqiu,Wang Zhen,et al.Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).[J].JOURNAL OF HEMATOLOGY & ONCOLOGY.2021,14(1):doi:10.1186/s13045-021-01033-1.
APA：
Shi Yuankai,Wu Jianqiu,Wang Zhen,Zhang Liling,Wang Zhao...&Wang Qian.(2021).Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)..JOURNAL OF HEMATOLOGY & ONCOLOGY,14,(1)
MLA：
Shi Yuankai,et al."Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).".JOURNAL OF HEMATOLOGY & ONCOLOGY 14..1(2021)

相关文献

[1]PD-1/PD-L1 Inhibitor Plus Chemotherapy Versus PD-1/PD-L1 Inhibitor in Microsatellite Instability Gastrointestinal Cancers: A Multicenter Retrospective Study [2]MRI-guided photothermal/photodynamic immune activation combined with PD-1 inhibitor for the multimodal combination therapy of melanoma and metastases [3]Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)(Open Access) [4]中国PD-1/PD-L1抑制剂治疗肺癌临床试验概况 [5]Ongoing clinical trials of PD-1 and PD-L1 inhibitors for lung cancer in China [6]A Multicenter Phase2 Trial of Linperlisib in Relapsed or Refractory Peripheral T/NK Cell Lymphomas [7]Phosphorylated AKT Protein Is Overexpressed in Human Peripheral T-cell Lymphomas and Predicts Decreased Patient Survival [8]4SCAR2.0: a multi-CAR-T therapy regimen for the treatment of relapsed/refractory B cell lymphomas. [9]Manifestation and prognostic value of EBV serology in nasal/nasopharyngeal T and NK-cell lymphomas. [10]Single-cell profiling identifies IL1Bhi macrophages associated with inflammation in PD-1 inhibitor-induced inflammatory arthritis

资源点击量：43377 今日访问量：0 总访问量：3120 更新日期：2024-09-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 四川省肿瘤医院 技术支持：重庆聚合科技有限公司 地址：成都市人民南路四段55号