2020
DOI: 10.1186/s13045-020-00871-9
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A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma

Abstract: Rituximab in combination with chemotherapy has shown efficacy in patients with diffuse large B-cell lymphoma (DLBCL) for more than 15 years. HLX01 was developed as the rituximab biosimilar following a stepwise approach to demonstrate biosimilarity in analytical, pre-clinical, and clinical investigations to reference rituximab. With demonstrated pharmacokinetic similarity, a phase 3 multi-center, randomized, parallel, double-blind study (HLX01-NHL03) was subsequently conducted to compare efficacy and safety bet… Show more

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Cited by 21 publications
(38 citation statements)
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“…Though not currently approved in the US, HLX01 (Shanghai Henlius Biotech Inc, Shanghai, China) has been evaluated in a comparative clinical study to assess the efficacy, safety, and immunogenicity of HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone compared with rituximab RP in the same combination dosing paradigm in patients with histologically confirmed CD20 + diffuse large B-cell lymphoma (Ann Arbor stages I-IV) every 21 days for up to six cycles. The primary efficacy endpoint of comparability of best ORR within six cycles of treatment was met [30].…”
Section: Discussionmentioning
confidence: 99%
“…Though not currently approved in the US, HLX01 (Shanghai Henlius Biotech Inc, Shanghai, China) has been evaluated in a comparative clinical study to assess the efficacy, safety, and immunogenicity of HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone compared with rituximab RP in the same combination dosing paradigm in patients with histologically confirmed CD20 + diffuse large B-cell lymphoma (Ann Arbor stages I-IV) every 21 days for up to six cycles. The primary efficacy endpoint of comparability of best ORR within six cycles of treatment was met [30].…”
Section: Discussionmentioning
confidence: 99%
“…In February 2015, CDE of NMPA launched “Guidelines for the research, development and technique assessment of biosimilar drugs (Trial)”, which accelerated the development of biosimilar drugs in China [6] . Since HLX01, the first biosimilar of rituximab, has been approved by NMPA in 2019 [19] , the R&D of CD20 monoclonal antibody has become the hotspot for lymphoma. In March 2020, CDE asked public comments on “Guidelines of clinical trials in rituximab biosimilar drugs (the draft for comments)” [20] .…”
Section: Discussionmentioning
confidence: 99%
“…Indeed, upregulated CD25 expression is related to a more aggressive course and an inferior outcome in DLBCL, FL, HL, and CLL [ 103 106 ]. It has also been shown to promote lymphomagenesis and drug resistance in T cell lymphomas [ 107 ].…”
Section: Adcs Explored In Various Clinical and Preclinical Settingsmentioning
confidence: 99%