Journal of Hematology & Oncology (Apr 2020)
A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma
- Yuankai Shi,
- Yongping Song,
- Yan Qin,
- Qingyuan Zhang,
- Xiaohong Han,
- Xiaonan Hong,
- Dong Wang,
- Wei Li,
- Yang Zhang,
- Jifeng Feng,
- Jianmin Yang,
- Huilai Zhang,
- Chuan Jin,
- Yu Yang,
- Jianda Hu,
- Zhao Wang,
- Zhengming Jin,
- Hang Su,
- Huaqing Wang,
- Haiyan Yang,
- Weijun Fu,
- Mingzhi Zhang,
- Xiaohong Zhang,
- Yun Chen,
- Xiaoyan Ke,
- Li Liu,
- Ding Yu,
- Guo’an Chen,
- Xiuli Wang,
- Jie Jin,
- Tao Sun,
- Xin Du,
- Ying Cheng,
- Pingyong Yi,
- Xielan Zhao,
- Chaoming Ma,
- Jiancheng Cheng,
- Katherine Chai,
- Alvin Luk,
- Eugene Liu,
- Xin Zhang
Affiliations
- Yuankai Shi
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College
- Yongping Song
- Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
- Yan Qin
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College
- Qingyuan Zhang
- Harbin Medical University Cancer Hospital
- Xiaohong Han
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College
- Xiaonan Hong
- Fudan University Shanghai Cancer Center
- Dong Wang
- Daping Hospital, Third Affiliated Hospital of the Army Medical University
- Wei Li
- The First Bethune Hospital of Jilin University
- Yang Zhang
- The Second Hospital of Dalian Medical University
- Jifeng Feng
- Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research
- Jianmin Yang
- Changhai Hospital
- Huilai Zhang
- Tianjin Medical University Cancer Institute & Hospital
- Chuan Jin
- Cancer Center of Guangzhou Medical University
- Yu Yang
- Fujian Provincial Cancer Hospital
- Jianda Hu
- Fujian Medical University Union Hospital
- Zhao Wang
- Beijing Friendship Hospital, Capital Medical University
- Zhengming Jin
- The First Affiliated Hospital of Soochow University
- Hang Su
- The 307th Hospital of Chinese People’s Liberation Army
- Huaqing Wang
- Tianjin People’s Hospital
- Haiyan Yang
- Zhejiang Cancer Hospital
- Weijun Fu
- Shanghai Changzheng Hospital
- Mingzhi Zhang
- The First Affiliated Hospital of Zhengzhou University
- Xiaohong Zhang
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Yun Chen
- Jinan Central Hospital Affiliated to Shandong University
- Xiaoyan Ke
- Peking University Third Hospital
- Li Liu
- Tangdu Hospital, Air Force Medical University
- Ding Yu
- Hubei Cancer Hospital
- Guo’an Chen
- The First Affiliated Hospital of Nanchang University
- Xiuli Wang
- The Second Hospital of Jilin University
- Jie Jin
- The First Affiliated Hospital, College of Medicine, Zhejiang University
- Tao Sun
- Liaoning Cancer Hospital & Institute
- Xin Du
- Guangdong Provincial People’s Hospital
- Ying Cheng
- Jilin Cancer Hospital
- Pingyong Yi
- Hunan Cancer Hospital
- Xielan Zhao
- Xiangya Hospital, Central South University
- Chaoming Ma
- Shanghai Henlius Biotech, Inc.
- Jiancheng Cheng
- Shanghai Henlius Biotech, Inc.
- Katherine Chai
- Shanghai Henlius Biotech, Inc.
- Alvin Luk
- Shanghai Henlius Biotech, Inc.
- Eugene Liu
- Shanghai Henlius Biotech, Inc.
- Xin Zhang
- Shanghai Henlius Biotech, Inc.
- DOI
- https://doi.org/10.1186/s13045-020-00871-9
- Journal volume & issue
-
Vol. 13,
no. 1
pp. 1 – 5
Abstract
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 between HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) and reference rituximab plus CHOP (R-CHOP) in a total of 407 treatment-naïve, CD20-positive DLBCL patients aged 18–80 years. The primary efficacy endpoint was best overall response rate (ORR) within six cycles of treatment in the per-protocol set (PPS). Secondary endpoints included 1-year efficacy outcomes, safety, and immunogenicity profile. The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], − 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%. The safety profile was comparable between the treatment groups, with a similar overall incidence of treatment-emergent adverse events (H-CHOP 99.5%, R-CHOP 99.0%, p = 1.000) and serious adverse events (H-CHOP 34.0%, R-CHOP 32.5%, p = 0.752). This study established bioequivalence in efficacy and safety between HLX01 and reference rituximab. The trial was registered at http://www.chinadrugtrials.org.cn on 26 August 2015 [#CTR20150583].
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