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卡瑞利珠单抗治疗复发或难治性经典型霍奇金淋巴瘤:多中心、单臂、Ⅱ期研究的随访延长。

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

机构信息

Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.

出版信息

Int J Cancer. 2022 Mar 15;150(6):984-992. doi: 10.1002/ijc.33852. Epub 2021 Nov 5.

Abstract

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.

摘要

卡瑞利珠单抗(一种针对程序性死亡受体-1 的高亲和力 IgG4 mAb)在复发或难治性经典霍奇金淋巴瘤(r/r cHL)患者中显示出强大的抗肿瘤活性、良好的耐受性和可控的安全性,这是基于一项 2 期研究的主要分析结果。在这里,我们报告了扩展随访结果。75 例患者在自体干细胞移植后未达到缓解或进展,或至少接受了 2 线系统化疗后,接受卡瑞利珠单抗 200mg,每 2 周 1 次。中位随访 36.2 个月(范围,7.2-38.1),独立中心评估的客观缓解率为 76.0%(95%置信区间[CI],64.7-85.1)。在 57 名应答者中,31 名(54.4%)持续应答。中位缓解持续时间为 31.7 个月(95%CI,16.7-未达到)。中位无进展生存期为 22.5 个月(95%CI,14.7-未达到)。36 个月总生存率为 82.7%(95%CI,72.0-89.5)。反应性毛细血管内皮增生(RCEP)发生在 97.3%的患者(73/75)中,但所有 RCEP 的严重程度均为 1 级或 2 级,其中 67.1%的患者(49/73)完全缓解。新的 RCEP 病变的发生罕见(12 个月时为 8/42[19.0%];24 个月时为 2/32[6.3%])。无治疗相关死亡,无新的毒性反应报告。随着随访时间的延长,卡瑞利珠单抗单药治疗在 r/r cHL 患者中继续提供强大、持久的缓解、长期生存和可管理的安全性。

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