机构:[1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.[2]Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.[3]Department of Oncology, Linyi Cancer Hospital, Linyi, China.[4]Department of Lymphoma, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[5]Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.首都医科大学附属北京友谊医院[6]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.[7]Department of Hematology, Lymphoma and Pediatric Oncology, Guangxi Medical University Affiliated Tumor Hospital and Oncology Medical College, Nanning, China.[8]Department of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.[9]Department of Hematology, Henan Cancer Hospital, Zhengzhou, China.河南省肿瘤医院[10]Department of Hematology, Jiangsu Province Hospital, Nanjing, China.江苏省人民医院[11]Department of Oncology, Shanghai East Hospital, Shanghai, China.[12]Department of Hematology, Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, China.中山大学附属第二医院[13]Department of Hematology, Gansu Provincial Cancer Hospital, Lanzhou, China.[14]Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.河北医科大学第四医院[15]Department of Lymphoma, Zhejiang Cancer浙江省肿瘤医院
Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients.
We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria.
Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30-22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2-51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related.
In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.
This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.
基金:
This study was funded by Genor Biopharma Co., Ltd., China. Special thanks to the following key members: Dr. Joe Zhou, Dr. Yu Wang (consulting), Huiyang Cheng, Dr. Haige Shen (consulting), Shengbin Ren, Dr. Yue Kang, Dr. Tong Li, Dr. Chao Gao, Dr. Xifang Liu, Yi Zheng, Xuexiang Zhang, Ming Tong, Chunyan Yuan, Gaijing Xue, Cuncun Li, Jing Zhang, Jie Guo, Dr. Ziyi Kan, Zhen Gao, Jun Lin, Ke Tan, and Hongbin Yan. Authors also appreciate the contributions from all the investigators, the patients and their families. Finally, authors thank Shiyu Jiang (Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University) for her medical writing assistance, funded by Genor Biopharma Co., Ltd., China.
第一作者机构:[1]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
通讯作者:
推荐引用方式(GB/T 7714):
Shi Yuankai,Wu Jianqiu,Wang Zhen,et al.Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).[J].JOURNAL OF HEMATOLOGY & ONCOLOGY.2021,14(1):doi:10.1186/s13045-021-01033-1.
APA:
Shi Yuankai,Wu Jianqiu,Wang Zhen,Zhang Liling,Wang Zhao...&Wang Qian.(2021).Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)..JOURNAL OF HEMATOLOGY & ONCOLOGY,14,(1)
MLA:
Shi Yuankai,et al."Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).".JOURNAL OF HEMATOLOGY & ONCOLOGY 14..1(2021)