Evidence map›Paper›PMID 35383885›Full record

ArticleBritish journal of haematology2022

A two-part, single-arm, multicentre, phase I study of zanubrutinib, a selective Bruton tyrosine kinase inhibitor, in Chinese patients with relapsed/refractory B-cell malignancies.

Yuqin Song, Mingyuan Sun, Junyuan Qi, Wei Xu, Jianfeng Zhou, Dengju Li, Jianyong Li, Lugui Qiu, Chenmu Du, Haiyi Guo and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03189524 (A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients With B-cell Lymphoma), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT03189524 phase1completednot on this map

A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients With B-cell Lymphoma

TypeinterventionalSponsorBeiGeneRan2016 to 2020Enrolled44ConditionsB-cell LymphomaArmsZanubrutinib
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Zanubrutinib: past, present, and future.Blood cancer journal · 2023
    Review
  13. Review
  14. Review
  15. Review
  16. Article
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

16 authors at 5 institutions in 2 countries.

Yuqin SongDepartment of Lymphoma, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.
Mingyuan SunNational Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Junyuan QiNational Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Wei XuDepartment of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.
Jianfeng ZhouDepartment of Hematology, Tongji Hospital, Tongji Medical College, Wuhan, China.ORCID 0000-0002-1332-9230
Dengju LiDepartment of Hematology, Tongji Hospital, Tongji Medical College, Wuhan, China.
Jianyong LiDepartment of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.
Lugui QiuNational Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Chenmu DuBeiGene (Beijing) Co., Ltd., Beijing, China.
Haiyi GuoBeiGene (Beijing) Co., Ltd., Beijing, China.
Jane HuangBeiGene (Beijing) Co., Ltd., Beijing, China.
Zhiyu TangBeiGene (Beijing) Co., Ltd., Beijing, China.
Ying OuBeiGene (Beijing) Co., Ltd., Beijing, China.
Binghao WuBeiGene (Beijing) Co., Ltd., Beijing, China.
Yiling YuBeiGene (Beijing) Co., Ltd., Beijing, China.
Jun ZhuDepartment of Lymphoma, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0003-3479-2547
BeiGene (China) · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNJiangsu Province Hospital · CNPeking University · CNTongji Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single-arm, multicentre, phase I study is the first study of zanubrutinib, a potent, specific, irreversible Bruton tyrosine kinase (BTK) inhibitor, in Chinese patients with relapsed/refractory B-cell malignancies. The objectives were to evaluate safety and preliminary anti-tumour activity. Forty-four patients received zanubrutinib 320 mg once daily (QD) (n = 10) or 160 mg twice daily (BID) (n = 34) until disease progression or unacceptable toxicity. 29.5% of patients received zanubrutinib for at least two years. The most common adverse event (AE) and the most common grade 3 or higher AE was neutrophil count decreased (54.5% and 25.0% respectively). Two patients (4.5%) discontinued treatment due to AEs and one treatment-emergent AE led to death. All haemorrhagic events were grade 1-2 (except for one non-serious grade 3 purpura). No second primary malignancies, tumour lysis syndrome, or atrial fibrillation/flutter occurred. The overall response rate was 52.3% (complete response rate, 18.2%). Patients with all cancer subtypes benefited from treatment. BTK C481S/R or L528W mutations were found in zanubrutinib-progressive patients. The safety/efficacy profiles of patients treated with 320 mg QD and 160 mg BID were comparable and similar daily area under the curve (AUC) was achieved. Overall, zanubrutinib was well tolerated and either of these two regimens is clinically practical. Registered at ClinicalTrials.gov (NCT03189524, on 16 June 2017, https://clinicaltrials.gov/ct2/show/NCT03189524).

Indexed as

Neoplasm Recurrence, LocalProtein Kinase InhibitorsAgammaglobulinaemia Tyrosine KinaseChinaChronic DiseaseHumansPiperidinesPyrazolesPyrimidinesAgammaglobulinaemia Tyrosine KinasePiperidinesProtein Kinase InhibitorsPyrazolesPyrimidineszanubrutinibB-cell malignanciesefficacyphase Isafetyzanubrutinib

Identifiers

PMID35383885
PMCPMC9321909
OpenAlexW4224132676

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.