Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients : Multi-center, single-arm, open-label, phase 2 study
© 2023 Wiley Periodicals LLC..
Orelabrutinib is a novel, small molecule, selective irreversible Bruton's tyrosine kinase inhibitor. The aim of this study was to evaluate the efficacy and safety in patients with refractory or relapsed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This is single-arm, multi-center, open-label, phase 2 study in 80 eligible Chinese patients, who were treated with monotherapy of orelabrutinib at 150 mg once daily. Overall response rate evaluated by an independent review committee was the primary endpoint, and secondary endpoints include progression-free survival, overall survival, and safety. Independent review committee assessed overall response rate was 92.5% (74/80); complete response 21.3% (17/80), partial response 60.0% (48/80), partial response with lymphocytosis 11.3% (9/80). At a 32.3-month median follow-up, the median progression-free survival had not been achieved, while the 30-month progression-free survival rate and overall survival rates were 70.9% (95% confidence interval [CI], 59.5-79.6) and 81.3% (95% CI, 70.8-88.2), respectively. Orelabrutinib also revealed substantial response in patients with high prognostic risks: overall response rates of patients carrying positive TP53 mutational status or del(17p), del(11q), as well as unmutated immunoglobulin heavy-chain variable region gene were 100%, 94.7%, and 93.9%, respectively. Most adverse events were in low grade, with 86.8% of AEs being Grade 1 or 2. Nearly 67% of patients were still receiving orelabrutinib after almost a 3-year follow-up. In conclusion, Orelabrutinib demonstrated compelling efficacy as well as safety profiles, with a noteworthy number of patients obtaining complete response in refractory or relapsed CLL/SLL.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:98 |
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| Enthalten in: |
American journal of hematology - 98(2023), 4 vom: 12. Apr., Seite 571-579 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Xu, Wei [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial, Phase II |
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| Anmerkungen: |
Date Completed 21.03.2023 Date Revised 03.05.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/ajh.26826 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM351941312 |
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| 100 | 1 | |a Xu, Wei |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients |b Multi-center, single-arm, open-label, phase 2 study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 21.03.2023 | ||
| 500 | |a Date Revised 03.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Wiley Periodicals LLC. | ||
| 520 | |a Orelabrutinib is a novel, small molecule, selective irreversible Bruton's tyrosine kinase inhibitor. The aim of this study was to evaluate the efficacy and safety in patients with refractory or relapsed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This is single-arm, multi-center, open-label, phase 2 study in 80 eligible Chinese patients, who were treated with monotherapy of orelabrutinib at 150 mg once daily. Overall response rate evaluated by an independent review committee was the primary endpoint, and secondary endpoints include progression-free survival, overall survival, and safety. Independent review committee assessed overall response rate was 92.5% (74/80); complete response 21.3% (17/80), partial response 60.0% (48/80), partial response with lymphocytosis 11.3% (9/80). At a 32.3-month median follow-up, the median progression-free survival had not been achieved, while the 30-month progression-free survival rate and overall survival rates were 70.9% (95% confidence interval [CI], 59.5-79.6) and 81.3% (95% CI, 70.8-88.2), respectively. Orelabrutinib also revealed substantial response in patients with high prognostic risks: overall response rates of patients carrying positive TP53 mutational status or del(17p), del(11q), as well as unmutated immunoglobulin heavy-chain variable region gene were 100%, 94.7%, and 93.9%, respectively. Most adverse events were in low grade, with 86.8% of AEs being Grade 1 or 2. Nearly 67% of patients were still receiving orelabrutinib after almost a 3-year follow-up. In conclusion, Orelabrutinib demonstrated compelling efficacy as well as safety profiles, with a noteworthy number of patients obtaining complete response in refractory or relapsed CLL/SLL | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Protein Kinase Inhibitors |2 NLM | |
| 700 | 1 | |a Zhou, Keshu |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Tingyu |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Shenmiao |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Lihong |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Kaiyang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Jianfeng |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Sujun |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Bing |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Zunmin |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Ting |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Huilai |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Jianda |e verfasserin |4 aut | |
| 700 | 1 | |a Ji, Chunyan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Shunqing |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Zhongjun |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Xin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Yongping |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Shuo |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Xinran |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jianyong |e verfasserin |4 aut | |
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