Penpulimab, an anti-PD-1 antibody, for heavily pretreated metastatic nasopharyngeal carcinoma: a single-arm phase II study
文献类型:期刊论文
作者 | Chen, Xiaozhong2; Wang, Wei3,4![]() |
刊名 | SIGNAL TRANSDUCTION AND TARGETED THERAPY
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出版日期 | 2024-06-19 |
卷号 | 9 |
ISSN号 | 2095-9907 |
DOI | 10.1038/s41392-024-01865-6 |
通讯作者 | Li, Jingao(lijingao@hotmail.com) ; Hu, Chaosu(hucsu62@163.com) |
英文摘要 | Penpulimab is an anti-programmed cell death-1 (PD-1) IgG1 antibody with no Fc gamma receptor (Fc gamma R) binding activity, and thus theoretically reduced immune-related adverse events (irAEs) while maintaining efficacy. This single-arm, phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma (NPC) who had failed two or more lines of previous systemic chemotherapy. Patients received 200-mg penpulimab intravenously every 2 weeks (4 weeks per cycle) until disease progression or intolerable toxicities. The primary endpoint was objective response rate (ORR) per RECIST (version 1.1), as assessed by an independent radiological review committee. The secondary endpoints included progression-free survival (PFS) and overall survival (OS). One hundred thirty patients were enrolled and 125 were efficacy evaluable. At the data cutoff date (September 28, 2022), 1 patient achieved complete response and 34 patients attained partial response. The ORR was 28.0% (95% CI 20.3-36.7%). The response was durable, with 66.8% still in response at 9 months. Thirty-three patients (26.4%) were still on treatment. The median PFS and OS were 3.6 months (95% CI = 1.9-7.3 months) and 22.8 months (95% CI = 17.1 months to not reached), respectively. Ten (7.6%) patients experienced grade 3 or higher irAEs. Penpulimab has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients, supporting further clinical development as third-line treatment of metastatic NPC. |
WOS关键词 | T-CELL-ACTIVATION ; ANTITUMOR-ACTIVITY ; RECURRENT ; PEMBROLIZUMAB ; MONOTHERAPY ; SAFETY |
资助项目 | Akeso Biopharma, Inc. |
WOS研究方向 | Biochemistry & Molecular Biology ; Cell Biology |
语种 | 英语 |
WOS记录号 | WOS:001249607900002 |
出版者 | SPRINGERNATURE |
资助机构 | Akeso Biopharma, Inc. |
源URL | [http://ir.hfcas.ac.cn:8080/handle/334002/136533] ![]() |
专题 | 中国科学院合肥物质科学研究院 |
通讯作者 | Li, Jingao; Hu, Chaosu |
作者单位 | 1.Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai, Peoples R China 2.Univ Chinese Acad Sci, Zhejiang Canc Hosp, Dept Radiat Oncol, Canc Hosp, Hangzhou, Peoples R China 3.Cent South Univ, Affiliated Canc Hosp, Xiangya Sch Med, Hunan Canc Hosp,Gastroenterol & Urol Dept 2, Changsha, Peoples R China 4.Clin Res Ctr Gastrointestinal Canc Hunan Prov, Changsha, Peoples R China 5.Guangzhou Med Univ, Affiliated Canc Hosp & Inst, Dept Med Oncol, Guangzhou, Peoples R China 6.Guangxi Med Univ, Affiliated Tumor Hosp, Dept Radiat Oncol, Nanning, Peoples R China 7.Guangxi Med Univ, Key Lab Early Prevent & Treatment Reg High Frequen, Minist Educ, Nanning, Peoples R China 8.Guangxi Med Univ, Guangxi Key Lab Early Prevent & Treatment Reg High, Nanning, Peoples R China 9.Xiamen Univ, Affiliated Hosp 1, Canc Ctr, Dept Radiat Oncol, Xiamen, Peoples R China 10.Shantou Univ, Canc Hosp, Dept Med Oncol, Med Coll, Shantou, Peoples R China |
推荐引用方式 GB/T 7714 | Chen, Xiaozhong,Wang, Wei,Zou, Qingfeng,et al. Penpulimab, an anti-PD-1 antibody, for heavily pretreated metastatic nasopharyngeal carcinoma: a single-arm phase II study[J]. SIGNAL TRANSDUCTION AND TARGETED THERAPY,2024,9. |
APA | Chen, Xiaozhong.,Wang, Wei.,Zou, Qingfeng.,Zhu, Xiaodong.,Lin, Qin.,...&Hu, Chaosu.(2024).Penpulimab, an anti-PD-1 antibody, for heavily pretreated metastatic nasopharyngeal carcinoma: a single-arm phase II study.SIGNAL TRANSDUCTION AND TARGETED THERAPY,9. |
MLA | Chen, Xiaozhong,et al."Penpulimab, an anti-PD-1 antibody, for heavily pretreated metastatic nasopharyngeal carcinoma: a single-arm phase II study".SIGNAL TRANSDUCTION AND TARGETED THERAPY 9(2024). |
入库方式: OAI收割
来源:合肥物质科学研究院
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