A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

Summary

The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.

Timeline

Start

2016-08-22

Primary completion

2019-09-05

Completion

2019-12-26

Outcome

Met primary endpoint

paper the ORR difference was -3.9% (95% CI - 9.1%-1.3%), falling within a ± 12.0% margin. PMID 33751401 ↗

release “has met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, namely: a phase III clinical trial” innoventbio.com ↗

Publications

• Song Y, Zhou H, Zhang H, Liu W, Shuang Y, Zhou K, Lv F, Xu H, Zhou J, Li W, Wang H, Zhang H, Huang H, Zhang Q, Xu W, Ge Z, Xiang Y, Wang S, Gao D, Yang S, Lin J, Wang L, Zou L, Zheng M, Liu J, Shao Z, Pang Y, Xia R, Chen Z, Hou M, Yao H, Feng R, Cai Z, Zhang M, Ran W, Liu L, Zeng S, Yang W, Liu P, Liang A, Zuo X, Zou Q, Ma J, Sang W, Guo Y, Zhang W, Cao Y, Li Y, Feng J, Du X, Zhang X, Zhao H, Zhou H, Yu J, Sun X, Zhu J, Qiu L. 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. Adv Ther. 2021 Apr;38(4):1889-1903. doi: 10.1007/s12325-020-01603-8. Epub 2021 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IBI301	Monoclonal antibody	375 mg/m2	Intravenous
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	100 mg	Oral
Background	Vindesine	Small molecule	4 mg	Intravenous

Indications