Camrelizumab for relapsed or refractory classical Hodgkin lymphoma: Extended follow-up of the multicenter, single-arm, Phase 2 study

被引:15
|
作者
Wu, Jianqiu [1 ,2 ,3 ]
Song, Yuqin [4 ]
Chen, Xinchuan [5 ]
Lin, Tongyu [6 ]
Cao, Junning [7 ]
Liu, Yanyan [8 ]
Zhao, Yaozhong [9 ]
Jin, Jie [10 ]
Huang, Haiwen [11 ]
Hu, Jianda [12 ]
Luo, Jun [13 ]
Zhang, Liling [14 ]
Xue, Hongwei [15 ]
Zhang, Qingyuan [16 ]
Wang, Weiwei [17 ]
Chen, Chunxia [18 ]
Feng, Jifeng [1 ,2 ,3 ]
Zhu, Jun [4 ]
机构
[1] Nanjing Med Univ, Dept Oncol, Jiangsu Canc Hosp, 42 Baiziting, Nanjing, Peoples R China
[2] Nanjing Med Univ, Jiangsu Inst Canc Res, 42 Baiziting, Nanjing, Peoples R China
[3] Nanjing Med Univ, Affiliated Canc Hosp, 42 Baiziting, Nanjing, Peoples R China
[4] Peking Univ Canc Hosp & Inst, Dept Lymphoma, Key Lab Carcinogenesis & Translat Res, Minist Educ, 52 Fucheng Rd, Beijing 100142, Peoples R China
[5] Sichuan Univ, West China Hosp, Dept Hematol, Chengdu, Peoples R China
[6] Sun Yat Sen Univ, Dept Med Oncol, Canc Ctr, Guangzhou, Peoples R China
[7] Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai, Peoples R China
[8] Zhengzhou Univ, Lymphat Comprehens Internal Med Ward, Affiliated Canc Hosp, Zhengzhou, Peoples R China
[9] Chinese Acad Med Sci, Blood Dis Hosp, Lymphoma Clin, Tianjin, Peoples R China
[10] Zhejiang Univ, Affiliated Hosp 1, Dept Hematol, Hangzhou, Peoples R China
[11] Soochow Univ, Dept Hematol, Affiliated Hosp 1, Suzhou, Peoples R China
[12] Fujian Med Univ, Dept Hematol, Union Hosp, Fuzhou, Peoples R China
[13] Guangxi Med Univ, Dept Hematol, Affiliated Hosp 1, Nanning, Peoples R China
[14] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Peoples R China
[15] Qingdao Univ, Dept Hematol, Affiliated Hosp, Qingdao, Peoples R China
[16] Harbin Med Univ, Dept Oncol, Canc Hosp, Harbin, Peoples R China
[17] Jiangsu Hengrui Pharmaceut Co Ltd, Dept Oncol, Shanghai, Peoples R China
[18] Jiangsu Hengrui Pharmaceut Co Ltd, Dept Clin Stat & Programming, Shanghai, Peoples R China
关键词
camrelizumab; classical Hodgkin lymphoma; long-term follow-up; PD-1; Phase 2 clinical trial; OPEN-LABEL; ANALYSIS REVEALS; PLUS APATINIB; PEMBROLIZUMAB; CHEMOTHERAPY; CARCINOMA; NIVOLUMAB; EFFICACY; THERAPY; FAILURE;
D O I
10.1002/ijc.33852
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Camrelizumab (a humanized high-affinity IgG4 mAb against programmed death-l) showed potent antitumor activity, well tolerance and controllable safety in patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL), based on the primary analysis of a Phase 2 study. Here, we present the extended follow-up outcomes. Seventy-five patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least two lines of systemic chemotherapies were enrolled to receive camrelizumab 200 mg every 2 weeks. With a median follow-up of 36.2 months (range, 7.2-38.1), objective response rate per independent central review was 76.0% (95% confidence interval [CI], 64.7-85.1). Among the 57 responders, 31 (54.4%) had ongoing responses. Median duration of response was 31.7 months (95% CI, 16.7-not reached). Median progression-free survival was 22.5 months (95% CI, 14.7-not reached). Thirty-six-month overall survival rate was 82.7% (95% CI, 72.0-89.5). Reactive capillary endothelial proliferation (RCEP) occurred in 97.3% of patients (73/75), but all RCEP were Grade 1 or 2 in severity and 67.1% of these patients (49/73) achieved complete resolution. Occurrence of new RCEP lesions was rare (8/42 [19.0%] at 12 months; 2/32 [6.3%] at 24 months). No treatment-related deaths occurred, and no new toxicities were reported. With extended follow-up, camrelizumab monotherapy continues to provide a robust and durable response, long survival and manageable safety in r/r cHL patients.
引用
收藏
页码:984 / 992
页数:9
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