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

医学 耐火材料(行星科学) 置信区间 临床研究阶段 内科学 移植 无进展生存期 总体生存率 淋巴瘤 化疗 外科 肿瘤科 胃肠病学 天体生物学 物理
作者
Jianqiu Wu,Yuqin Song,Xinchuan Chen,Tongyu Lin,Junning Cao,Yanyan Liu,Yongqiang Zhao,Jie Jin,Haiwen Huang,Jianda Hu,Jie Luo,Liling Zhang,Xue Hou,Qingyuan Zhang,Weiwei Wang,Chunxia Chen,Jifeng Feng,Jun Zhu
出处
期刊:International Journal of Cancer [Wiley]
卷期号:150 (6): 984-992 被引量:13
标识
DOI:10.1002/ijc.33852
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.
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