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Published in: BMC Cancer 1/2024

Open Access 01-12-2024 | Diffuse Large B-Cell Lymphoma | Research

Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study

Authors: Yan Qin, Yongping Song, Dong Wang, Ou Bai, Jifeng Feng, Xiuhua Sun, Lihua Qiu, Jianmin Yang, Yu Yang, Zhao Wang, Jianda Hu, Huaqing Wang, Hang Su, Zhengming Jin, Wenbin Qian, Chuan Jin, Mingzhi Zhang, Ding Yu, Li Liu, Guoan Chen, Yarong Li, Tao Sun, Jie Jin, Huizheng Bao, Xin Du, Hui Zhou, Gan Fu, Yuankai Shi

Published in: BMC Cancer | Issue 1/2024

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Abstract

HLX01 (HanliKang®) is a rituximab biosimilar that showed bioequivalence to reference rituximab in untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) in the phase 3 HLX01-NHL03 study. Here, we report the 5-year follow-up results from the open-label extension part. Patients were randomised to either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 plus CHOP (H-CHOP) every 21 days for up to six cycles. The primary efficacy endpoint was overall survival (OS), and secondary efficacy endpoint was progression-free survival (PFS). Of the 407 patients enrolled in HLX01-NHL03, 316 patients (H-CHOP = 157; R-CHOP = 159) were included in the 5-year follow-up for a median duration of 65.1 (range, 2.2–76.5) months. 96.5% of the patients had an International Prognostic Index (IPI) of 1 or 2, and 17.7% had bone marrow involvement. The 5-year OS rates were 81.0% (95% CI: 74.9–87.5%) and 75.4% (95% CI: 68.9–82.6%)( HR: 0.75, 95% CI 0.47–1.20; p = 0.23) while 5-year PFS rates were 77.7% (95% CI: 71.4–84.6%) and 73.0% (95% CI: 66.3–80.3%) (HR: 0.84, 95% CI 0.54–1.30; p = 0.43) in the H-CHOP and R-CHOP groups, respectively. Treatment outcomes did not differ between groups regardless of IPI score and were consistent with the primary analysis. H-CHOP and R-CHOP provided no significant difference in 5-year OS or PFS in previously untreated patients with low or low-intermediate risk DLBCL.
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Metadata
Title
Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study
Authors
Yan Qin
Yongping Song
Dong Wang
Ou Bai
Jifeng Feng
Xiuhua Sun
Lihua Qiu
Jianmin Yang
Yu Yang
Zhao Wang
Jianda Hu
Huaqing Wang
Hang Su
Zhengming Jin
Wenbin Qian
Chuan Jin
Mingzhi Zhang
Ding Yu
Li Liu
Guoan Chen
Yarong Li
Tao Sun
Jie Jin
Huizheng Bao
Xin Du
Hui Zhou
Gan Fu
Yuankai Shi
Publication date
01-12-2024
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2024
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-024-11876-9

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