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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

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Abstract

Introduction

Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL).

Methods

This multicenter, randomized, double-blind, parallel-group, phase 3 trial compared IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP), was conducted in 68 centers across China. Eligible patients with untreated CD20 positive (CD20+) DLBCL randomly received IBI301 (375 mg/m2) plus the standard CHOP or rituximab (375 mg/m2) plus the standard CHOP for six cycles of a 21-day cycle. The primary end point was the overall remission rate (ORR). Efficacy equivalence was defined if 95% CIs for the ORR difference between the two groups were within a ± 12.0% margin.

Results

Between August 22, 2016, and September 5, 2018, 419 patients were randomly allocated into the IBI301 group (N = 209) and rituximab group (N = 210). In the full analysis set, the ORR was 89.9% and 93.8% in the IBI301 and rituximab groups, respectively, and the ORR difference was -3.9% (95% CI − 9.1%–1.3%), falling within a ± 12.0% margin. The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).

Conclusions

IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20+ DLBCL.

Trial Registration

This trial is registered on ClinicalTrials.gov (NCT02867566).

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Acknowledgements

The authors are grateful to all the patients participating in this trial, and all their families. They also thank the investigators and staff.

Funding

This study was funded by Innovent Biologics and co-funded by Eli Lilly and Company. The sponsors also funded the journal’s Rapid Service fee.

Medical Writing Assistance

We thank the editorial staff of Innovent Biologics, Inc. (the study sponsor), Xia Yin, for providing writing support.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

Hui Zhou (Innovent), Jie Yu, and Xing Sun are employees of Innovent Biologics, Inc. Yuqin Song, Hui Zhou, Huilai Zhang, Wei Liu, Yuerong Shuang, Keshu Zhou, Fangfang Lv, Hao Xu, Jianfeng Zhou, Wei Li, Huaqing Wang, Hongyu Zhang, Haiwen Huang, Qingyuan Zhang, Wei Xu, Zheng Ge, Ying Xiang, Shuye Wang, Da Gao, Shun’e Yang, Jinying Lin, Lin Wang, Liqun Zou, Meifang Zheng, Jing Liu, Zonghong Shao, Ying Pang, Ruixiang Xia, Zhendong Chen, Ming Hou, Hongxia Yao, Ru Feng, Zhen Cai, Mingzhi Zhang, Wenhua Ran, Lin Liu, Shan Zeng, Wei Yang, Peng Liu, Aibin Liang, XuelanZuo, Qingfeng Zou, Junxun Ma, Wei Sang, Ye Guo, Wei Zhang, Yongqing Cao, Yan Li, Jifeng Feng, Xin Du, Xiaohong Zhang, Hongguo Zhao, Hui Zhou, Jun Zhu, and Lugui Qiu have nothing to disclose.

Compliance with Ethics Guidelines

The study was approved by the ethics committee of the Institute of Hematology and Blood Diseases Hospital and the ethics committee at each center. This study was performed in accordance with the guidance on the ethical principles of the Declaration of Helsinki and the Good Clinical Practice (GCP). Written informed consent was obtained from all patients.

Data Availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author information

Authors and Affiliations

  1. State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China

    Wei Liu & Lugui Qiu

  2. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China

    Yuqin Song & Jun Zhu

  3. Department of Lymphoma and Hematology, Hunan Province Cancer Hospital, Changsha, China

    Hui Zhou

  4. Department of Lymphoma, Tianjin Cancer Hospital, Tianjin, China

    Huilai Zhang

  5. Cancer Chemotherapy Center, Jiangxi Province Cancer Hospital, Nanchang, China

    Yuerong Shuang

  6. Hematology Department, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China

    Keshu Zhou

  7. Oncology Department, Fudan University Cancer Hospital, Shanghai, China

    Fangfang Lv

  8. Hematology Department, Yancheng City No. 1 People’s Hospital, Yancheng, China

    Hao Xu

  9. Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China

    Jianfeng Zhou

  10. Hematology Department, The First Hospital of Jilin University, Changchun, China

    Wei Li

  11. Oncology Department, Tianjin City People’s Hospital, Tianjin, China

    Huaqing Wang

  12. Oncology Department, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China

    Hongyu Zhang

  13. Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China

    Haiwen Huang

  14. Department of Oncology, Affiliated Cancer Hospital of Harbin Medical University, Harbin, China

    Qingyuan Zhang

  15. Hematology Department, Jiangsu Province Hospital, Nanjing, China

    Wei Xu

  16. Hematology Department, Zhongda Hospital Southeast, Nanjing, China

    Zheng Ge

  17. Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China

    Ying Xiang

  18. Hematology Department, First Affiliated Hospital of Harbin Medical University, Harbin, China

    Shuye Wang

  19. Hematology Department, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China

    Da Gao

  20. Department of Lymphoma and Breast Cancer, First Affiliated Hospital of Xinjiang Medical University, Urumchi, China

    Shun’e Yang

  21. Department of Hematological Rheumatology, People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China

    Jinying Lin

  22. Oncology Department, Hainan General Hospital, Haikou, China

    Lin Wang

  23. Department of Oncology, West China Hospital Sichuan University, Chengdu, China

    Liqun Zou

  24. Department of Hematology, Linyi Cancer Hospital, Linyi, China

    Meifang Zheng

  25. Hematology Department, Third Xiangya Hospital of Central South University, Changsha, China

    Jing Liu

  26. Hematology Department, General Hospital, Tianjin Medical University, Tianjin, China

    Zonghong Shao

  27. Hematology Department, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

    Ying Pang

  28. Hematology Department, First Affiliated Hospital of Anhui Medical University, Hefei, China

    Ruixiang Xia

  29. Oncology Department, Second Affiliated Hospital of Anhui Medical University, Hefei, China

    Zhendong Chen

  30. Hematology Department, Qilu Hospital of Shandong University, Jinan, China

    Ming Hou

  31. Hematology Department, Hainan General Hospital, Haikou, China

    Hongxia Yao

  32. Hematology Department, Nanfang Hospital, Guangzhou, China

    Ru Feng

  33. Department of Hematology, First Affiliated Hospital of Zhejiang Medical University, Hangzhou, China

    Zhen Cai

  34. Oncology Department, First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China

    Mingzhi Zhang

  35. Cancer Center, Chongqing Three-Gorge Central Hospital, Chongqing, China

    Wenhua Ran

  36. Hematology Department, First Affiliated Hospital of Chongqing Medical University, Chongqing, China

    Lin Liu

  37. Oncology Department, Xiangya Hospital Central South University, Changsha, China

    Shan Zeng

  38. Hematology Department, Shengjing Hospital of China Medical University, Shenyang, China

    Wei Yang

  39. Hematology Department, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China

    Peng Liu

  40. Hematology Department, Tongji Hospital of Tongji University, Shanghai, China

    Aibin Liang

  41. Hematology Department, Zhongnan Hospital of Wuhan, Wuhan, China

    Xuelan Zuo

  42. Department of Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China

    Qingfeng Zou

  43. Department of Oncology, Chinese PLA General Hospital, Beijing, China

    Junxun Ma

  44. Department of Hematology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China

    Wei Sang

  45. Oncology Department, Shanghai East Hospital, Shanghai, China

    Ye Guo

  46. Hematology Department, Peking Union Medical College Hospital, Beijing, China

    Wei Zhang

  47. Department of Hematology and Oncology, First Hospital of Changsha, Changsha, China

    Yongqing Cao

  48. Hematology Department, First Affiliated Hospital of China Medical University, Shenyang, China

    Yan Li

  49. Oncology Department, Jiangsu Cancer Hospital, Nanjing, China

    Jifeng Feng

  50. Hematology Department, Second People’s Hospital of Shenzhen, Shenzhen, China

    Xin Du

  51. Hematology Department, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

    Xiaohong Zhang

  52. Hematology Department, Affiliated Hospital of Qingdao University, Qingdao, China

    Hongguo Zhao

  53. Innovent Biologics, Inc, Suzhou, China

    Hui Zhou, Jie Yu & Xing Sun

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  1. Yuqin Song
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  2. Hui Zhou
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  30. Ming Hou
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  31. Hongxia Yao
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  32. Ru Feng
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  33. Zhen Cai
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  35. Wenhua Ran
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  36. Lin Liu
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  37. Shan Zeng
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Corresponding authors

Correspondence to Jun Zhu or Lugui Qiu.

Additional information

Lugui Qiu and Yuqin Song are co-first authors of the article. Lugui Qiu and Jun Zhu are co-corresponding authors.

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Song, Y., Zhou, H., Zhang, H. et al. 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 38, 1889–1903 (2021). https://doi.org/10.1007/s12325-020-01603-8

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  • DOI: https://doi.org/10.1007/s12325-020-01603-8

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