Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Summary

Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Timeline

Start

2015-10

Primary completion

2018-05

Completion

2018-05

Outcome

Met primary endpoint

paper 1.4% (95% confidence interval [CI], - 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%. PMID 32299513 ↗

release “The risk difference between the two ORR6cycles was 1.4% (95%CI: −3.59%, 6.32%), which falls within the pre-defined equivalence margin” henlius.com ↗

Publications

• Results Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, Wang D, Li W, Zhang Y, Feng J, Yang J, Zhang H, Jin C, Yang Y, Hu J, Wang Z, Jin Z, Su H, Wang H, Yang H, Fu W, Zhang M, Zhang X, Chen Y, Ke X, Liu L, Yu D, Chen G, Wang X, Jin J, Sun T, Du X, Cheng Y, Yi P, Zhao X, Ma C, Cheng J, Chai K, Luk A, Liu E, Zhang X. A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma. J Hematol Oncol. 2020 Apr 16;13(1):38. doi: 10.1186/s13045-020-00871-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX01	Monoclonal antibody	375 mg/m2	Intravenous
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Doxorubicin	Other / unclassified	—	—
Background	Prednisone	Other / unclassified	—	—
Background	Vincristine	Small molecule	—	—

Indications