학술논문
Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial
Document Type
Original Paper
Author
Song, Yuqin; Zhou, Hui; Zhang, Huilai; Liu, Wei; Shuang, Yuerong; Zhou, Keshu; Lv, Fangfang; Xu, Hao; Zhou, Jianfeng; Li, Wei; Wang, Huaqing; Zhang, Hongyu; Huang, Haiwen; Zhang, Qingyuan; Xu, Wei; Ge, Zheng; Xiang, Ying; Wang, Shuye; Gao, Da; Yang, Shun’e; Lin, Jinying; Wang, Lin; Zou, Liqun; Zheng, Meifang; Liu, Jing; Shao, Zonghong; Pang, Ying; Xia, Ruixiang; Chen, Zhendong; Hou, Ming; Yao, Hongxia; Feng, Ru; Cai, Zhen; Zhang, Mingzhi; Ran, Wenhua; Liu, Lin; Zeng, Shan; Yang, Wei; Liu, Peng; Liang, Aibin; Zuo, Xuelan; Zou, Qingfeng; Ma, Junxun; Sang, Wei; Guo, Ye; Zhang, Wei; Cao, Yongqing; Li, Yan; Feng, Jifeng; Du, Xin; Zhang, Xiaohong; Zhao, Hongguo; Zhou, Hui; Yu, Jie; Sun, Xing; Zhu, Jun; Qiu, Lugui
Source
Advances in Therapy. 38(4):1889-1903
Subject
Language
English
ISSN
0741-238X
1865-8652
1865-8652
Abstract
Introduction: Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL).Methods: This multicenter, randomized, double-blind, parallel-group, phase 3 trial compared IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP), was conducted in 68 centers across China. Eligible patients with untreated CD20 positive (CD20+ ) DLBCL randomly received IBI301 (375 mg/m2 ) plus the standard CHOP or rituximab (375 mg/m2 ) plus the standard CHOP for six cycles of a 21-day cycle. The primary end point was the overall remission rate (ORR). Efficacy equivalence was defined if 95% CIs for the ORR difference between the two groups were within a ± 12.0% margin.Results: Between August 22, 2016, and September 5, 2018, 419 patients were randomly allocated into the IBI301 group (N = 209) and rituximab group (N = 210). In the full analysis set, the ORR was 89.9% and 93.8% in the IBI301 and rituximab groups, respectively, and the ORR difference was -3.9% (95% CI − 9.1%–1.3%), falling within a ± 12.0% margin. The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).Conclusions: IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20+ DLBCL.Trial Registration: This trial is registered on ClinicalTrials.gov (NCT02867566).