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
Article Swipe
Yuqin Song
,
Mingyuan Sun
,
Junyuan Qi
,
Wei Xu
,
Jianfeng Zhou
,
Dengju Li
,
Jianyong Li
,
Lugui Qiu
,
Chenmu Du
,
Haiyi Guo
,
Jane Huang
,
Zhiyu Tang
,
Ying Ou
,
Binghao Wu
,
Yiling Yu
,
Jun Zhu
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1111/bjh.18162
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1111/bjh.18162
Summary 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 ).
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1111/bjh.18162
- OA Status
- green
- Cited By
- 24
- References
- 23
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4224132676
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4224132676Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1111/bjh.18162Digital Object Identifier
- Title
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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 malignanciesWork title - Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2022Year of publication
- Publication date
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2022-04-05Full publication date if available
- Authors
-
Yuqin Song, Mingyuan Sun, Junyuan Qi, Wei Xu, Jianfeng Zhou, Dengju Li, Jianyong Li, Lugui Qiu, Chenmu Du, Haiyi Guo, Jane Huang, Zhiyu Tang, Ying Ou, Binghao Wu, Yiling Yu, Jun ZhuList of authors in order
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https://doi.org/10.1111/bjh.18162Publisher landing page
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YesWhether a free full text is available
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greenOpen access status per OpenAlex
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https://www.ncbi.nlm.nih.gov/pmc/articles/9321909Direct OA link when available
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Medicine, Adverse effect, Internal medicine, Gastroenterology, Refractory (planetary science), Oncology, Biology, AstrobiologyTop concepts (fields/topics) attached by OpenAlex
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24Total citation count in OpenAlex
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2025: 7, 2024: 8, 2023: 7, 2022: 2Per-year citation counts (last 5 years)
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23Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.twice | 55 |
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| abstract_inverted_index.tumour | 133 |
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| corresponding_author_ids | https://openalex.org/A5030040961 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 16 |
| corresponding_institution_ids | https://openalex.org/I20231570, https://openalex.org/I4210093964 |
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| sustainable_development_goals[0].display_name | Good health and well-being |
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| citation_normalized_percentile.is_in_top_10_percent | True |