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

• Published in: Advances in therapy 2021-04, Vol.38 (4), p.1889-1903
• Main Authors: 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, Yu, Jie, Sun, Xing, Zhu, Jun, Qiu, Lugui
• Format: Article
• Language: English
• Subjects: Animals; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biosimilar Pharmaceuticals - therapeutic use; Cardiology; China; Endocrinology; Humans; Internal Medicine; Lymphoma, Large B-Cell, Diffuse - drug therapy; Medicine; Medicine & Public Health; Mice; NCT; NCT02867566; Oncology; Original Research; Pharmacology/Toxicology; Reference Standards; Rheumatology; Rituximab - therapeutic use; Treatment Outcome; Vincristine - therapeutic use
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-020-01603-8

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/m 2 ) plus the standard CHOP or rituximab (375 mg/m 2 ) 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).