Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis
BackgroundTirabrutinib is a potent, irreversible, and highly selective Bruton’s tyrosine kinase (BTK) inhibitor that has demonstrated significant therapeutic activity in patients with relapsed or refractory B-cell lymphoma. However, the safety and efficacy of tirabrutinib monotherapy have not been s...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1559056/full |
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| author | Jingfei Wang Hai-en Cheng Yanhua Sun Zhenfeng Li Yunke Zang Yuying Zhao Guimao Yang Zhijun Liu Yaqi Sun Yanli Sun |
| author_facet | Jingfei Wang Hai-en Cheng Yanhua Sun Zhenfeng Li Yunke Zang Yuying Zhao Guimao Yang Zhijun Liu Yaqi Sun Yanli Sun |
| author_sort | Jingfei Wang |
| collection | DOAJ |
| description | BackgroundTirabrutinib is a potent, irreversible, and highly selective Bruton’s tyrosine kinase (BTK) inhibitor that has demonstrated significant therapeutic activity in patients with relapsed or refractory B-cell lymphoma. However, the safety and efficacy of tirabrutinib monotherapy have not been systematically assessed. This meta-analysis aims to assess the safety and efficacy of tirabrutinib monotherapy in patients with B-cell lymphoma.MethodsWe conducted a comprehensive literature search in Embase, PubMed, Web of Science, and Cochrane Library databases to identify prospective clinical trials evaluating tirabrutinib monotherapy in B-cell lymphoma. Data on efficacy and safety were extracted and analyzed.ResultsA total of seven studies were included in the meta-analysis. The clinical trials primarily involved patients with chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia (WM). The pooled overall response rate (ORR) was 72.5%, with complete response (CR) rate of 18.6%, stable disease (SD) rate of 13.8%, and partial response (PR) rate of 41.1%. The highest median progression-free survival (mPFS) was observed in patients with CLL, reaching 38.5 months. Neutropenia was the most common adverse event (AE), both all grades and grade ≥3. Additionally, a high incidence of skin-related AEs was reported.ConclusionTirabrutinib monotherapy demonstrates a manageable safety profile and promising efficacy in patients with B-cell lymphoma. However, these findings need to be confirmed by larger and higher-quality randomized controlled trials in the future. Further research should also explore the long-term effects and potential benefits of combination therapies involving tirabrutinib.Systematic Review RegistrationIdentifier CRD42024552721. |
| format | Article |
| id | doaj-art-1c8dca5e934044049177e715d764d1b6 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-1c8dca5e934044049177e715d764d1b62025-08-20T03:44:32ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-04-011610.3389/fphar.2025.15590561559056Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysisJingfei Wang0Hai-en Cheng1Yanhua Sun2Zhenfeng Li3Yunke Zang4Yuying Zhao5Guimao Yang6Zhijun Liu7Yaqi Sun8Yanli Sun9School of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaSchool of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaDepartment of Hematology, Weifang People’s Hospital, Weifang, ChinaMedicine Research Center of Shandong Second Medical University, Shandong Second Medical University, Weifang, ChinaSchool of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaSchool of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaDepartment of Clinical Laboratory, Affiliated Hospital of Shandong Second Medical University, Weifang, ChinaSchool of Basic Medicine, Shandong Second Medical University, Weifang, ChinaSchool of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaSchool of Medical Laboratory, Shandong Second Medical University, Weifang, ChinaBackgroundTirabrutinib is a potent, irreversible, and highly selective Bruton’s tyrosine kinase (BTK) inhibitor that has demonstrated significant therapeutic activity in patients with relapsed or refractory B-cell lymphoma. However, the safety and efficacy of tirabrutinib monotherapy have not been systematically assessed. This meta-analysis aims to assess the safety and efficacy of tirabrutinib monotherapy in patients with B-cell lymphoma.MethodsWe conducted a comprehensive literature search in Embase, PubMed, Web of Science, and Cochrane Library databases to identify prospective clinical trials evaluating tirabrutinib monotherapy in B-cell lymphoma. Data on efficacy and safety were extracted and analyzed.ResultsA total of seven studies were included in the meta-analysis. The clinical trials primarily involved patients with chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia (WM). The pooled overall response rate (ORR) was 72.5%, with complete response (CR) rate of 18.6%, stable disease (SD) rate of 13.8%, and partial response (PR) rate of 41.1%. The highest median progression-free survival (mPFS) was observed in patients with CLL, reaching 38.5 months. Neutropenia was the most common adverse event (AE), both all grades and grade ≥3. Additionally, a high incidence of skin-related AEs was reported.ConclusionTirabrutinib monotherapy demonstrates a manageable safety profile and promising efficacy in patients with B-cell lymphoma. However, these findings need to be confirmed by larger and higher-quality randomized controlled trials in the future. Further research should also explore the long-term effects and potential benefits of combination therapies involving tirabrutinib.Systematic Review RegistrationIdentifier CRD42024552721.https://www.frontiersin.org/articles/10.3389/fphar.2025.1559056/fullBtk inhibitortirabrutinibB-cell lymphomas/leukemiasafetyefficacy |
| spellingShingle | Jingfei Wang Hai-en Cheng Yanhua Sun Zhenfeng Li Yunke Zang Yuying Zhao Guimao Yang Zhijun Liu Yaqi Sun Yanli Sun Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis Frontiers in Pharmacology Btk inhibitor tirabrutinib B-cell lymphomas/leukemia safety efficacy |
| title | Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis |
| title_full | Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis |
| title_fullStr | Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis |
| title_full_unstemmed | Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis |
| title_short | Efficacy and safety of tirabrutinib monotherapy in relapsed or refractory B-cell lymphomas/leukemia: a meta-analysis |
| title_sort | efficacy and safety of tirabrutinib monotherapy in relapsed or refractory b cell lymphomas leukemia a meta analysis |
| topic | Btk inhibitor tirabrutinib B-cell lymphomas/leukemia safety efficacy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1559056/full |
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