Efficacy and safety of cadonilimab in previously treated recurrent or metastatic nasopharyngeal carcinoma(COMPASSION-06): A phase II multicenter study

被引:2
|
作者
Chen, Qiu-Yan [1 ]
Luo, Ying [2 ]
Qu, Song [3 ]
Wu, De-Hua [4 ]
Chen, Xiao-Zhong [5 ]
Chen, Don-Ping [6 ]
Qin, Xin-Tian [7 ]
Lin, Qin [8 ]
Jin, Feng [9 ]
Lin, Shao-Jun [10 ]
Yao, Zhi-Fang [11 ]
Liu, Wei [11 ]
Wang, Zhongmin Maxwell [11 ]
Li, Bai-Yong [11 ]
Xia, Michelle [11 ]
Xu, Rui-Hua [12 ]
Tang, Lin-Quan [1 ]
Mai, Hai-Qiang [1 ]
机构
[1] Sun Yat Sen Univ, Collaborat Innovat Ctr Canc Med, Dept Nasopharyngeal Carcinoma, State Key Lab Oncol South China,Guangdong Key Lab, 651 Dongfeng Rd East, Guangzhou 510060, Peoples R China
[2] Hunan Canc Hosp, Dept Thorac Radiotherapy, Changsha, Peoples R China
[3] Guangxi Med Univ, Dept Radiotherapy, Affiliated Tumor Hosp, Nanning, Peoples R China
[4] Southern Med Univ, Nanfang Hosp, Dept Radiotherapy, Guangzhou, Peoples R China
[5] Zhejiang Canc Hosp, Dept Oncol, Hangzhou, Peoples R China
[6] Guangzhou Med Univ, Affiliated Canc Hosp & Inst, Dept Radiotherapy, Guangzhou, Peoples R China
[7] Guangdong Pharmaceut Univ, Dept Oncol, Affiliated Hosp 1, Guangzhou, Peoples R China
[8] Xiamen Univ, Dept Oncol Radiotherapy, Affiliated Hosp 1, Xiamen, Peoples R China
[9] Guizhou Med Univ, Dept Oncol, Affiliated Canc Hosp, Guiyang, Peoples R China
[10] Fujian Canc Hosp, Dept Head & Neck Neoplasm Radiotherapy, Fuzhou, Peoples R China
[11] Akeso Biopharm Inc, Zhongshan, Peoples R China
[12] Sun Yat Sen Univ, Collaborat Innovat Ctr Canc Med, Dept Med Oncol, State Key Lab Oncol South China,Canc Ctr, Guangzhou, Peoples R China
基金
中国国家自然科学基金;
关键词
Cadonilimab; Bi-specific antibody; BsA; Nasopharyngeal carcinoma; NPC; Immune checkpoint inhibitor; Immunotherapy; ANTITUMOR-ACTIVITY; CARCINOMA; NIVOLUMAB; IPILIMUMAB; BLOCKADE; TRIAL; PD-L1;
D O I
10.1016/j.oraloncology.2024.106723
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objective: This study was designed to assess the efficacy and safety of cadonilimab monotherapy, a first-in-class, bi-specific PD-1/CTLA-4 antibody, in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC). Patients and methods: This multicenter, open-label, single-arm, phase II clinical trial enrolled patients with R/M-NPC who had failed first-line platinum-based chemotherapy and second-line single agent or combined chemotherapy, and immunotherapy-naive. Patients received cadonilimab for 6 mg/kg once every 2 weeks (Q2W). The primary endpoint was objective response rate (ORR) in full analysis set (FAS) assessed by investigators according to RECIST v.1.1. The secondary endpoint included progression-free survival (PFS), overall survival (OS), duration of response (DoR), time to response (TTR) and safety. Results: A total of 23 patients were assessed. The median time from first dose to data cutoff was 16.56 (range, 0.8-25.2) months. ORR was 26.1 % (95 %CI:10.2-48.4). The ORR were 44.4 % (95 %CI: 13.7-78.8) and 14.3 % (95 %CI:1.8-42.8) in patients with tumor PD-L1 expression >= 50 % and <50 %, respectively. ORR was achieved in 40.0 % (95 %CI:12.2-73.8) of patients with EBV-DNA level <4000 IU/ml (n = 10) and 15.4 % (95 %CI:1.9-45.4) of those with >= 4000 IU/ml. The median PFS was 3.71 months (95 %CI: 1.84-9.30). respectively. Median OS was not reached, and the 12-month OS rate was 79.7 % (95 % CI:54.5-91.9). Only two patients (8.3 %) experienced Grade >= 3 treatment-related adverse events (TRAEs) with hypothyroidism (30.4 %), rash (21.7 %) and pruritus (21.7 %) being the most prevalent TRAEs. Conclusion: Cadonilimab monotherapy demonstrated a promising efficacy and manageable toxicity in patients with previously treated R-M/NPC and provide an efficacious salvage treatment option.
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页数:7
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