Long-term follow-up of zimberelimab in relapsed or refractory classic Hodgkin lymphoma: Insights from the phase II YH-S001-04 clinical trial

被引:0
作者
Kan, Suisui [1 ]
Bai, Hai [2 ]
Liu, Hui [3 ]
Cui, Jie [4 ]
Ke, Xiaoyan [5 ]
Zhang, Huilai [6 ]
Liu, Lihong [7 ]
Yan, Dongmei [8 ]
Jiang, Yongsheng [9 ]
Zang, Aimin [10 ]
Qi, Junyuan [11 ,12 ]
Wang, Li [13 ]
Liu, Zhuogang [14 ]
Xu, Bing [15 ]
Zhang, Ying [16 ]
Zhang, Zhihui [17 ]
Zhao, Xielan [18 ]
Hu, Chunhong [19 ]
Yang, Shenmiao [20 ]
Zhou, Hui [21 ]
Shi, Jinsheng [21 ,22 ]
Shao, Zonghong [22 ,23 ]
Xiang, Ying [23 ,24 ]
Lin, Ningjing [24 ,25 ]
Zhang, Mingzhi [1 ]
机构
[1] Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Peoples R China
[2] 940 Hosp Joint Logist Support Force PLA, Dept Gastroenterol, Lanzhou, Peoples R China
[3] Beijing Hosp, Dept Hematol, Beijing, Peoples R China
[4] Gansu Prov Canc Hosp, Dept Pathol, Lanzhou, Peoples R China
[5] Peking Univ Third Hosp, Dept Hematol, Beijing, Peoples R China
[6] Tianjin Med Univ, Canc Inst & Hosp, Dept Lymphoma, Tianjin, Peoples R China
[7] Hebei Med Univ, Hosp 4, Hosp 4, Dept Hematol, Shijiazhuang, Peoples R China
[8] Xuzhou Med Univ, Affiliated Hosp, Dept Hematol, Xuzhou, Peoples R China
[9] Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Med Coll, Dept Oncol, Wuhan, Peoples R China
[10] Hebei Med Univ, Affiliate Hosp, Dept Med Oncol, Baoding, Peoples R China
[11] Chinese Acad Med Sci, Inst Hematol, Dept Lymphoma, Tianjin 300020, Peoples R China
[12] Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China
[13] Jiangsu Prov Hosp, Dept Hematol, Nanjing 210029, Jiangsu, Peoples R China
[14] China Med Univ, Sheng Jing Hosp, Dept Hematol, Shenyang, Peoples R China
[15] Xiamen Univ, Affiliated Hosp 1, Dept Hematol, Xiamen, Peoples R China
[16] Guangdong Med Coll, Affiliated Hosp, Dept Oncol, Zhanjiang, Peoples R China
[17] Sichuan Canc Hosp & Inst, Dept Med Oncol, Chengdu, Peoples R China
[18] Cent South Univ, Xiangya Hosp, Dept Hematol, Changsha, Peoples R China
[19] Cent South Univ, Second Xiangya Hosp, Dept Oncol, Changsha, Peoples R China
[20] Peking Univ, Peoples Hosp, Dept Hematol, Beijing, Peoples R China
[21] Cent South Univ, Affiliated Canc Hosp Xiangya Sch Med, Affiliated Canc Hosp, Dept Lymphoma & Hematol,Xiangyi Sch Med, Changsha, Peoples R China
[22] Cangzhou Cent Hosp, Dept Oncol, Cangzhou, Peoples R China
[23] Tianjin Med Univ, Gen Hosp, Dept Hematol, Tianjin, Peoples R China
[24] Chongqing Canc Hosp, Dept Hematol & Oncol, Chongqing, Peoples R China
[25] Peking Univ Canc Hosp & Inst, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, Dept Lymphoma, Beijing, Peoples R China
关键词
Hodgkin Lymphoma; Relapsed/Refractory; PD-1; inhibitors; Zimberelimab; Efficacy; Safety; CELL TRANSPLANTATION; ADAPTED TREATMENT; SINGLE-ARM; OPEN-LABEL; PEMBROLIZUMAB; NIVOLUMAB; MULTICENTER; SAFETY;
D O I
10.1016/j.leukres.2024.107633
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Treating relapsed or refractory classical Hodgkin lymphoma (R/R cHL) remains challenging. This report extends the three-year follow-up period for the phase II YH-S001-04 trial, expanding upon the initial 15.8- month analysis. Methods: Zimberelimab 240 mg was administered every two weeks for two years or until disease progression or death. The endpoint was the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Results: The median follow-up was 38.0 months (3.5-42.8 months). The ORR was 91.6 % (95 % CI, 83.8-95.9). Median PFS was 23.6 months, with a longer PFS in responders (28.5 months) compared to non-responders (9.2 months) (P=0.0098). Complete responders had longer mPFS than partial responders (Not reached vs. 28.5 months, P =0.3469). Relapsed patients had improved mPFS compared to refractory cHL (23.6 vs. 10.6 months, P =0.0061). Patients with <3 lines of therapy showed longer mPFS compared to >= 3 lines (not reached vs. 23.6 months, P =0.0095). The 3-year OS rate was 94.0 % (95 % CI, 85.9-97.4). No serious adverse events with incidence >5 %. Conclusions: With encouraging data on both PFS and OS, zimberelimab demonstrates ongoing efficacy and safety in treating R/R cHL, supporting zimberelimab as an effective treatment alternative for R/R cHL (NCT03655483).
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