Eur J Cancer:GLS-010 (zimberelimab)在中国复发或难治性经典霍奇金淋巴瘤(r/r-cHL)患者中的疗效和安全性

2021-11-10 yd2015 MedSci原创

研究表明,GLS-010 (zimberelimab) 表现出对中国复发或难治性经典霍奇金淋巴瘤(r/r-cHL)患者有效和安全。需要长期随访来证实这些临床益处。

GLS-010 (zimberelimab)是一种新型、全人类、抗PD-1单克隆抗体,在晚期实体肿瘤中显示出良好的疗效和安全性。近期,European Journal of Cancer杂志发表一项北京大学肿瘤医院朱军教授主导的II期研究(NCT03655483),旨在评价GLS-010 (zimberelimab)在中国复发或难治性经典霍奇金淋巴瘤(r/r-cHL)患者中的疗效和安全性。

这是一项中国的24个中心进行的单臂、开放标签、多中心II期临床研究,。纳入了经过2线或以上治疗后的r/r-cHL患者。患者静脉注射GLS-010 (zimberelimab) (240mg,每2周1次),直到病情进展、死亡、不可接受的毒性或同意退出。主要终点是由一个独立的放射学审查委员会(IRC)评估的客观缓解率。

2018年8月至2019年4月,纳入85例患者。截至2020年4月18日,62名参与者仍在接受治疗,其中23人停止了治疗。治疗中断的原因为PD (n=13, 15.3%)、AEs (n=8, 9.4%)、参与者要求(n=1, 1.2%)和其他原因(n=1, 1.2%)。

所有患者都接受了二线或更多的治疗。男性49例(57.6%)。HL II期12例(14.1%),III期19例(22.4%),IV期48例(56.5%)。12例(14.1%)患者接受了ASCT治疗,2例(2.4%)患者接受了本妥昔单抗治疗。

在IRC评估中,28例患者(32.9%)达到CR, 49例患者(57.6%)达到PR, 5例患者(5.9%)获得SD, 3例患者(3.5%)PD。ORR为90.6% (95% CI 82.3-95.9%)。

           疗效评估

中位随访时间为15.8个月(范围1.1-19.9)。截至2020年4月, 9例(10.6%)患者PD和1例患者PD前死亡。6个月的无进展生存(PFS)率为90% (95% CI 80.0-94.7)。12个月的PFS率为78% (95% CI 67.5-85.6), 12个月的OS率为99% (95% CI 91.9-99.8)。中位DOR、中位PFS和中位OS均未达到。

          预后

85例患者(100%)发现AEs, 79例患者(92.9%)发现TRAE。>10%发生率的TRAE包括甲状腺功能减退(n=18, 21.2%),中性粒细胞计数下降(n=17, 20.0%),丙氨酸转氨酶升高(n =17, 20.0%),白细胞计数下降(n=16, 18.8%),体重增加(n=11, 12.9%),血胆红素升高(n=10, 11.8%),天门冬氨酸转氨酶升高(10.6%),发热(10.6%),上呼吸道感染(10.6%),瘙痒(10.6%),肝功能异常(10.6%),和贫血(10.6%)。41例(48.2%)患者出现免疫相关不良事件,包括甲状腺功能减退(16例,18.8%)、丙氨酸氨基转移酶升高(8例,9.4%)、皮肤瘙痒(7例,8.2%)、肝功能异常(6例,7.1%)和血胆红素升高(5例,5.6%)。

               不良事件

综上,研究表明,GLS-010 (zimberelimab) 表现出对中国复发或难治性经典霍奇金淋巴瘤(r/r-cHL)患者有效和安全。需要长期随访来证实这些临床益处。

原始出处:

Lin N, Zhang M, Bai H, Liu H, Cui J, Ke X, Zhang H, Liu L, Yan D, Jiang Y, Zang A, Qi J, Wang L, Liu Z, Xu B, Zhang Y, Zhang Z, Zhao X, Hu C, Yang S, Zhou H, Shi J, Shao Z, Xiang Y, Zhu J, Song Y, Zhu J. Efficacy and safety of GLS-010 (zimberelimab) in patients with relapsed or refractory classical Hodgkin lymphoma: A multicenter, single-arm, phase II study. Eur J Cancer. 2021 Aug 27:S0959-8049(21)00479-2. doi: 10.1016/j.ejca.2021.07.021. Epub ahead of print. PMID: 34462189.

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    2022-06-16 snf701207
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    2021-11-12 freve