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01-04-2021 | Rituximab | Original Research

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

Authors: Yuqin Song, Hui Zhou, Huilai Zhang, Wei Liu, Yuerong Shuang, Keshu Zhou, Fangfang Lv, Hao Xu, Jianfeng Zhou, Wei Li, Huaqing Wang, Hongyu Zhang, Haiwen Huang, Qingyuan Zhang, Wei Xu, Zheng Ge, Ying Xiang, Shuye Wang, Da Gao, Shun’e Yang, Jinying Lin, Lin Wang, Liqun Zou, Meifang Zheng, Jing Liu, Zonghong Shao, Ying Pang, Ruixiang Xia, Zhendong Chen, Ming Hou, Hongxia Yao, Ru Feng, Zhen Cai, Mingzhi Zhang, Wenhua Ran, Lin Liu, Shan Zeng, Wei Yang, Peng Liu, Aibin Liang, Xuelan Zuo, Qingfeng Zou, Junxun Ma, Wei Sang, Ye Guo, Wei Zhang, Yongqing Cao, Yan Li, Jifeng Feng, Xin Du, Xiaohong Zhang, Hongguo Zhao, Hui Zhou, Jie Yu, Xing Sun, Jun Zhu, Lugui Qiu

Published in: Advances in Therapy | Issue 4/2021

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).

Available only for authorised users

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Title: 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
Authors: Yuqin Song
Hui Zhou
Huilai Zhang
Wei Liu
Yuerong Shuang
Keshu Zhou
Fangfang Lv
Hao Xu
Jianfeng Zhou
Wei Li
Huaqing Wang
Hongyu Zhang
Haiwen Huang
Qingyuan Zhang
Wei Xu
Zheng Ge
Ying Xiang
Shuye Wang
Da Gao
Shun’e Yang
Jinying Lin
Lin Wang
Liqun Zou
Meifang Zheng
Jing Liu
Zonghong Shao
Ying Pang
Ruixiang Xia
Zhendong Chen
Ming Hou
Hongxia Yao
Ru Feng
Zhen Cai
Mingzhi Zhang
Wenhua Ran
Lin Liu
Shan Zeng
Wei Yang
Peng Liu
Aibin Liang
Xuelan Zuo
Qingfeng Zou
Junxun Ma
Wei Sang
Ye Guo
Wei Zhang
Yongqing Cao
Yan Li
Jifeng Feng
Xin Du
Xiaohong Zhang
Hongguo Zhao
Hui Zhou
Jie Yu
Xing Sun
Jun Zhu
Lugui Qiu
Publication date: 01-04-2021
Publisher: Springer Healthcare
Keywords: Rituximab
Rituximab
Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Published in: Advances in Therapy / Issue 4/2021
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-020-01603-8

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