Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.
机构：[1]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.[2]Hematology Department, Peking University Third Hospital, Beijing, China.[3]Oncology Department, The Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.[4]Hematology Department, Jiangsu Province Hospital, Nanjing, China.江苏省人民医院[5]Department of Lymphoma/Head and Neck Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.[6]Hematology Department, West China Hospital Sichuan University, Chengdu, China.四川大学华西医院[7]Oncology Department, The First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.[8]Oncology Department, Tianjin Union Medical Center Nankai University Affiliated Hospital, Tianjin, China.[9]Forth Medical Department, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.[10]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.[11]Hematology Department, Tangdu Hospital, The Medical University of Air Forces, Xi'an, China.[12]Bone Marrow Transplantation Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.浙江大学医学院附属第一医院[13]Hematology Department, Xiangya Hospital Central South University, Changsha, China.[14]Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.[15]Hematology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.[16]Hematology Department, The Third Xiangya Hospital of Central South University, Changsha, China.[17]Innovent Biologics, Inc., Suzhou, China
This multicenter, randomized, double-blind, parallel-controlled trial aimed to compare the pharmacokinetics (PK) of IBI301 with rituximab in patients with CD20-positive (CD20+) B-cell lymphoma, who achieved a complete response/unconfirmed complete response after standard treatments. Patients were randomized (1:1) to receive IBI301 or rituximab (375 mg/m2, IV). Patients who continuously benefitted from the trial after the PK phase underwent the extension phase to receive up to three cycles of 3-month-cycle of rituximab/IBI301 maintenance therapy. PK was described using the area under the serum concentration-time curve from time zero to infinity (AUC0-inf), AUC from time zero to last quantifiable concentration (AUC0-t), and maximum serum concentration (Cmax). Pharmacodynamics (PD), incidence of adverse events and immunogenicity were evaluated. PK was defined equivalent, if 90% confidence intervals (CIs) for geometric mean ratios of PK endpoints fell within the margin of 0.8-1.25. Overall, 181 patients were enrolled in IBI301 (n = 89) and rituximab (n = 92) groups. Geometric mean ratios of AUC0-inf, AUC0-t, and Cmax were 0.91 (90% CI 0.85, 0.97), 0.91 (90% CI 0.86, 0.97), and 0.96 (90% CI 0.92, 1.01) between treatment groups, all within the bioequivalence range. Peripheral CD19+ and CD20+ B-cell counts were similar at each prespecified time point between the groups. No difference in immunogenicity was observed. The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab). IBI301 was PK bioequivalent to rituximab in patients with CD20+ B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab.
基金：
Te study was granted by the National Major Science and Technology Project (2017ZX09304024),
sponsored by Innovent Biologics, Inc. and co-funded by Eli Lilly and Company.
第一作者机构：[1]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Jiang Bo,Ke Xiaoyan,Zhang Qingyuan,et al.Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.[J].Scientific reports.2020,10(1):11676.doi:10.1038/s41598-020-68360-0.
APA：
Jiang Bo,Ke Xiaoyan,Zhang Qingyuan,Xu Wei,Su Hang...&Qiu Lugui.(2020).Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study..Scientific reports,10,(1)
MLA：
Jiang Bo,et al."Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.".Scientific reports 10..1(2020):11676
