Song Yuqin, Zhou Keshu, Jin Chuan, Qian Zhengzi, Hou Ming, Fan Lei, Li Fei, Ding Kaiyang, Zhou Hui, Li Xiaoling, Chen Bing, Sun Xiuhua, Song Xianmin, Jiang Ming, Zhang Qingyuan, Liu Lihong, Yu Guohua, Hu Yu, Zhao Zheng, Liu Ligen, Xue Hongwei, Luo Jun, He Bai, Jin Xiaoping, Zhao Min, Li Baiyong, Xia Yu, Zhu Jun
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.
Department of Hematology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
Front Oncol. 2022 Jul 7;12:925236. doi: 10.3389/fonc.2022.925236. eCollection 2022.
Nearly all anti-PD-1 antibodies are of the IgG4 isotype, and thus possess residual FcR effector functions. Such anti-PD-1 antibodies are also associated with immune tolerance and escape due to instability of the CH3 domain and Fc-Fc interaction. In this trial, we examined the efficacy and safety of penpulimab, a novel IgG1 anti-PD-1 antibody that does not bind to the Fc receptor, in patients with refractory or relapsed classical Hodgkin lymphoma (R/R cHL).
Adult patients (≥18 years of age) with R/R cHL received 200 mg penpulimab once biweekly until disease progression or unacceptable toxicities for a maximum of 24 months. The primary endpoint was objective response rate (ORR) based on the Independent Radiology Review Committee per Lugano 2014 criteria. Secondary endpoints included progression-free survival (PFS), overall survival (OS), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs).
A total of 94 patients were enrolled. The median follow-up was 15.8 months. The ORR was 89.4% (95% CI 80.8%, 95.0%) in the full analysis set (85 patients). Forty (47.1%) patients achieved complete remission, 36 (42.4%) patients achieved partial remission. The 12-month PFS rate was 72.1% (95% CI 60.5%, 80.8%) and the 18-month OS rate was 100%. Totally 97.9% (92/94) of patients experienced at least one TRAE. The rate of grade 3 and above TRAEs was 26.6% (25/94). In addition, 51 (54.3%) patients experienced an irAE, and 4 (4.3%) patients developed grade 3 or above irAEs. No irAE-related death occurred.
Penpulimab was effective and safe in patients with R/R cHL.
几乎所有抗程序性死亡蛋白1（PD-1）抗体均为IgG4同种型，因此具有残留的Fc受体效应子功能。此类抗PD-1抗体还因CH3结构域的不稳定性和Fc-Fc相互作用而与免疫耐受及逃逸相关。在本试验中，我们研究了一种新型不与Fc受体结合的IgG1抗PD-1抗体派安普利单抗在难治性或复发性经典型霍奇金淋巴瘤（R/R cHL）患者中的疗效和安全性。
年龄≥18岁的R/R cHL成年患者每两周接受一次200 mg派安普利单抗治疗，直至疾病进展或出现不可接受的毒性，最长治疗24个月。主要终点是基于独立放射学审查委员会按照2014年卢加诺标准评估的客观缓解率（ORR）。次要终点包括无进展生存期（PFS）、总生存期（OS）、治疗相关不良事件（TRAEs）和免疫相关不良事件（irAEs）。
共纳入94例患者。中位随访时间为15.8个月。全分析集（85例患者）的ORR为89.4%（95%CI 80.8%，95.0%）。40例（47.1%）患者达到完全缓解，36例（42.4%）患者达到部分缓解。12个月PFS率为72.1%（95%CI 60.5%，80.8%），18个月OS率为100%。共有97.9%（92/94）的患者经历了至少一次TRAE。3级及以上TRAE的发生率为26.6%（25/94）。此外，51例（54.3%）患者发生了irAE，4例（4.3%）患者发生了3级或以上irAE。未发生与irAE相关的死亡。
派安普利单抗在R/R cHL患者中有效且安全。
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