Penpulimab, an anti-PD-1 antibody, for heavily pretreated metastatic nasopharyngeal carcinoma: a single-arm phase II study

Chen，Xiaozhong1; Wang，Wei2,3; Zou，Qingfeng4; Zhu，Xiaodong5; Lin，Qin6; Jiang，Yi7; Sun，Yan8; Shen，Liangfang9; Wang，Lin10; Zou，Guorong11; Lin，Xiaoyan12; Lin，Shaojun13; Li，Minying14; Wang，Ying15; Xu，Ruilian16; Ao，Rui17; Wang，Rensheng18; Lin，Haifeng19; Huang，Shuang1; Xu，Tingting20,21,22; Li，Wenting23; Xia，Mengying23; Xia，Yu23; Wang，Zhongmin23; Li，Baiyong23; Li，Jingao24,25; Hu，Chaosu20,21,22

2024-12-01

10.1038/s41392-024-01865-6

Signal Transduction and Targeted Therapy   影响因子和分区

2095-9907

2059-3635

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.

英语

其他

2-s2.0-85196190673

Scopus

1.Department of Radiation Oncology,Cancer Hospital of the University of Chinese,Academy of Sciences (Zhejiang Cancer Hospital),Hangzhou,China
2.Gastroenterology and Urology Department II,Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University,Changsha,China
3.Clinical Research Center for Gastrointestinal Cancer in Hunan Province,Changsha,China
4.Department of Medical Oncology,Affiliated Cancer Hospital & amp; Institute of Guangzhou Medical University,Guangzhou,China
5.Department of Radiation Oncology,Guangxi Medical University Affiliated Tumor Hospital & amp; Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor (Guangxi Medical University),Ministry of Education & amp; 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 of Medical Oncology,Cancer Hospital of Shantou University Medical College,Shantou,China
8.Department of Radiation Oncology,Peking University Cancer Hospital & amp; Institute,Beijing,China
9.Department of Oncology,Xiangya Hospital Central South University,Changsha,China
10.Department of Medical Oncology,Hainan General Hospital,Hainan Affiliated 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 Fujian Medical University,Fujian Cancer Hospital,Fuzhou,China
14.Department of Radiation Therapy for Thoracic Tumors,Zhongshan City People’s Hospital,Zhongshan,China
15.Tumor Radiotherapy Center,Chongqing University Cancer Hospital,Chongqing Cancer Hospital,Chongqing Cancer Institute,Chongqing,China
16.Department of Oncology,Shenzhen People’s Hospital (The Second Clinical Medical College,Jinan University; The First Affiliated Hospital,Southern University of Science and Technology),Shenzhen,China
17.Oncology Center,Sichuan Academy of Medical Sciences & amp; Sichuan Provincial People’s Hospital,School of Medicine UESTC,Chengdu,China
18.Department of Radiation Oncology,The First Affiliated Hospital of Guangxi Medical University,Nanning,China
19.Department of Medical Oncology,The Second Affiliated Hospital of Hainan Medica University,Haikou,China
20.Department of Radiation Oncology,Fudan University,Shanghai Cancer Center,Shanghai,China
21.Department of Oncology,Shanghai Medical College,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 Cancer Hospital,Nanchang Medical College),Nanchang,China

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(1).

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(1).

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 9.1(2024).