Evidence map›Paper›PMID 33751401›Full record

Trial reportAdvances in therapy2021

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.

Yuqin Song, Hui Zhou, Huilai Zhang, Wei Liu, Yuerong Shuang, Keshu Zhou, Fangfang Lv, Hao Xu, Jianfeng Zhou, Wei Li and 47 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02867566 (A Multicenter, Randomized, Double-blind, Controlled, Phase III Study to Evaluate the Efficacy and Safety of IBI301), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02867566 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Controlled, Phase III Study to Evaluate the Efficacy and Safety of IBI301 (Recombinant Chimeric Anti-CD20 Monoclonal Antibody ) in Combination With CHOP Regimen Versus Rituximab in Combination With CHOP Regimen in Treatment-naïve Patients With Diffuse Large B-cell Lymphoma (DLBCL)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2016 to 2019Enrolled420ConditionsDiffuse, Large B-Cell, LymphomaArmsIBI301 plus CHOP, Rituximab plus CHOP
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Pooled it
  4. Trial
  5. Journal of cancer research and clinical oncology · 2025
    Article
  6. Article
  7. Review
  8. Article
  9. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

57 authors at 20 institutions in 1 country.

Yuqin SongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.
Hui ZhouDepartment of Lymphoma and Hematology, Hunan Province Cancer Hospital, Changsha, China.
Huilai ZhangDepartment of Lymphoma, Tianjin Cancer Hospital, Tianjin, China.
Wei LiuState 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.
Yuerong ShuangCancer Chemotherapy Center, Jiangxi Province Cancer Hospital, Nanchang, China.
Keshu ZhouHematology Department, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
Fangfang LvOncology Department, Fudan University Cancer Hospital, Shanghai, China.
Hao XuHematology Department, Yancheng City No. 1 People's Hospital, Yancheng, China.
Jianfeng ZhouHematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.
Wei LiHematology Department, The First Hospital of Jilin University, Changchun, China.
Huaqing WangOncology Department, Tianjin City People's Hospital, Tianjin, China.
Hongyu ZhangOncology Department, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China.
Haiwen HuangDepartment of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Qingyuan ZhangDepartment of Oncology, Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.
Wei XuHematology Department, Jiangsu Province Hospital, Nanjing, China.
Zheng GeHematology Department, Zhongda Hospital Southeast, Nanjing, China.
Ying XiangDepartment of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China.
Shuye WangHematology Department, First Affiliated Hospital of Harbin Medical University, Harbin, China.
Da GaoHematology Department, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.
Shun'e YangDepartment of Lymphoma and Breast Cancer, First Affiliated Hospital of Xinjiang Medical University, Urumchi, China.
Jinying LinDepartment of Hematological Rheumatology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
Lin WangOncology Department, Hainan General Hospital, Haikou, China.
Liqun ZouDepartment of Oncology, West China Hospital Sichuan University, Chengdu, China.
Meifang ZhengDepartment of Hematology, Linyi Cancer Hospital, Linyi, China.
Jing LiuHematology Department, Third Xiangya Hospital of Central South University, Changsha, China.
Zonghong ShaoHematology Department, General Hospital, Tianjin Medical University, Tianjin, China.
Ying PangHematology Department, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Ruixiang XiaHematology Department, First Affiliated Hospital of Anhui Medical University, Hefei, China.
Zhendong ChenOncology Department, Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Ming HouHematology Department, Qilu Hospital of Shandong University, Jinan, China.
Hongxia YaoHematology Department, Hainan General Hospital, Haikou, China.
Ru FengHematology Department, Nanfang Hospital, Guangzhou, China.
Zhen CaiDepartment of Hematology, First Affiliated Hospital of Zhejiang Medical University, Hangzhou, China.
Mingzhi ZhangOncology Department, First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.
Wenhua RanCancer Center, Chongqing Three-Gorge Central Hospital, Chongqing, China.
Lin LiuHematology Department, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Shan ZengOncology Department, Xiangya Hospital Central South University, Changsha, China.
Wei YangHematology Department, Shengjing Hospital of China Medical University, Shenyang, China.
Peng LiuHematology Department, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.
Aibin LiangHematology Department, Tongji Hospital of Tongji University, Shanghai, China.
Xuelan ZuoHematology Department, Zhongnan Hospital of Wuhan, Wuhan, China.
Qingfeng ZouDepartment of Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.
Junxun MaDepartment of Oncology, Chinese PLA General Hospital, Beijing, China.
Wei SangDepartment of Hematology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Ye GuoOncology Department, Shanghai East Hospital, Shanghai, China.
Wei ZhangHematology Department, Peking Union Medical College Hospital, Beijing, China.
Yongqing CaoDepartment of Hematology and Oncology, First Hospital of Changsha, Changsha, China.
Yan LiHematology Department, First Affiliated Hospital of China Medical University, Shenyang, China.
Jifeng FengOncology Department, Jiangsu Cancer Hospital, Nanjing, China.
Xin DuHematology Department, Second People's Hospital of Shenzhen, Shenzhen, China.
Xiaohong ZhangHematology Department, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Hongguo ZhaoHematology Department, Affiliated Hospital of Qingdao University, Qingdao, China.
Hui ZhouInnovent Biologics, Inc, Suzhou, China.
Jie YuInnovent Biologics, Inc, Suzhou, China.
Xing SunInnovent Biologics, Inc, Suzhou, China.
Jun ZhuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China. zhu-jun2017@outlook.com.
Lugui QiuState 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. qiulg@ihcams.ac.cn.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNCentral South University · CNChina Medical University · CNHainan General Hospital · CNHunan Cancer Hospital · CNPeking University · CNAnhui Medical University · CNChinese PLA General Hospital · CNChongqing Cancer Hospital · CNChongqing Three Gorges Central Hospital · CNFifth Affiliated Hospital of Sun Yat-sen University · CNFirst Affiliated Hospital of Anhui Medical University · CNFirst Affiliated Hospital of Chongqing Medical University · CNFirst Affiliated Hospital of Harbin Medical University · CNFirst Affiliated Hospital of Soochow University · CNFirst Affiliated Hospital of Xinjiang Medical University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst Affiliated Hospital Zhejiang University · CNFirst Hospital of Jilin University · CNFudan University Shanghai Cancer Center · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients 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).

methodsThis 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

resultsBetween 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).

conclusionsIBI301 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

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

Indexed as

Biosimilar PharmaceuticalsLymphoma, Large B-Cell, DiffuseAnimalsAntineoplastic Combined Chemotherapy ProtocolsChinaHumansMiceReference StandardsRituximabTreatment OutcomeVincristineBiosimilar PharmaceuticalsRituximabVincristineBiosimilarCHOPDLBCLIBI301Rituximab

Identifiers

PMID33751401
OpenAlexW3190394261

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.