机构：[1]Department of Radiation Oncology, Cancer Hospital of the University of Chinese, Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China浙江省肿瘤医院[2]Gastroenterology andUrology Department II, Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China[3]Clinical Research Centerfor Gastrointestinal Cancer in Hunan Province, Changsha, China[4]Department of Medical Oncology, Affiliated Cancer Hospital & Institute of Guangzhou Medical University,Guangzhou, China[5]Department of Radiation Oncology, Guangxi Medical University Affiliated Tumor Hospital & Key Laboratory of Early Prevention and Treatment for RegionalHigh Frequency Tumor (Guangxi Medical University), Ministry of Education & Guangxi Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor,Guangxi Medical University, Nanning, China[6]Department of Radiation Oncology, Cancer Center, The First Affiliated Hospital of Xiamen University, Xiamen, China[7]Department ofMedical Oncology, Cancer Hospital of Shantou University Medical College, Shantou, China[8]Department of Radiation Oncology, Peking University Cancer Hospital & Institute,Beijing, China[9]Department of Oncology, Xiangya Hospital Central South University, Changsha, China[10]Department of Medical Oncology, Hainan General Hospital, HainanAffiliated Hospital of Hainan Medical University, Haikou, China[11]Department of Oncology, The Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou,China[12]Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China[13]Department of Radiation Oncology, Clinical Oncology School of FujianMedical University, Fujian Cancer Hospital, Fuzhou, China[14]Department of Radiation Therapy for Thoracic Tumors, Zhongshan City People’s Hospital, Zhongshan, China[15]TumorRadiotherapy Center, Chongqing University Cancer Hospital, Chongqing Cancer Hospital, Chongqing Cancer Institute, Chongqing, China[16]Department of Oncology, ShenzhenPeople’s Hospital (The Second Clinical Medical College, Jinan University,The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China深圳市康宁医院深圳市人民医院深圳医学信息中心中国医科大学附属盛京医院中国医科大学盛京医院[17]Oncology Center, Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, School of Medicine UESTC, Chengdu, China四川省人民医院[18]Department of RadiationOncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China[19]Department of Medical Oncology, The Second Affiliated Hospital of Hainan MedicaUniversity, Haikou, China[20]Department of Radiation Oncology, Fudan University, Shanghai Cancer Center, Shanghai, China[21]Department of Oncology, Shanghai MedicalCollege, Fudan University, Shanghai, China[22]Shanghai Key Laboratory of Radiation Oncology, Shanghai, China[23]Akeso Biopharma Inc., Zhongshan, China[24]Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China[25]NHC Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma (Jiangxi CancerHospital, Nanchang Medical College), Nanchang, China
Penpulimab is an anti-programmed cell death-1 (PD-1) IgG1 antibody with no Fc gamma receptor (FcγR) 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.
第一作者机构：[1]Department of Radiation Oncology, Cancer Hospital of the University of Chinese, Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
共同第一作者：
通讯作者：
通讯机构：[20]Department of Radiation Oncology, Fudan University, Shanghai Cancer Center, Shanghai, China[21]Department of Oncology, Shanghai MedicalCollege, Fudan University, Shanghai, China[22]Shanghai Key Laboratory of Radiation Oncology, Shanghai, China[24]Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China[25]NHC Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma (Jiangxi CancerHospital, Nanchang Medical College), Nanchang, China
推荐引用方式(GB/T 7714)：
Xiaozhong Chen,Wei Wang,Qingfeng Zou,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(1):148.doi:10.1038/s41392-024-01865-6.
APA：
Xiaozhong Chen,Wei Wang,Qingfeng Zou,Xiaodong Zhu,Qin Lin...&Chaosu Hu.(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,(1)
MLA：
Xiaozhong Chen,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..1(2024):148
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