| Title | Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients: Multi-center, single-arm, open-label, phase 2 study |
| Authors | Xu, Wei Zhou, Keshu Wang, Tingyu Yang, Shenmiao Liu, Lihong Hu, Yu Zhang, Wei Ding, Kaiyang Zhou, Jianfeng Gao, Sujun Xu, Bing Zhu, Zunmin Liu, Ting Zhang, Huilai Hu, Jianda Ji, Chunyan Wang, Shunqing Xia, Zhongjun Wang, Xin Li, Yan Song, Yongping Ma, Shuo Tang, Xinran Zhang, Bin Li, Jianyong |
| Affiliation | Nanjing Med Univ, Jiangsu Prov Hosp, Pukou CLL Ctr, Collaborat Innovat Ctr Canc Personalized Med,Affil, Nanjing, Peoples R China Zhengzhou Univ, Henan Canc Hosp, Dept Hematol, Affiliated Canc Hosp, Zhengzhou, Peoples R China Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol, Natl Clin Res Ctr Blood Dis, State Key Lab Expt Hematol,Haihe Lab Cell Ecosyst, Tianjin, Peoples R China Chinese Acad Med Sci & Peking Union Med Coll, Blood Dis Hosp, Tianjin, Peoples R China Peking Univ, Dept Hematol, Peoples Hosp, Beijing, Peoples R China Hebei Med Univ, Dept Hematol, Hosp 4, Shijiazhuang, Peoples R China Huazhong Univ Sci & Technol, Union Hosp, Inst Hematol, Tongji Med Coll, Wuhan, Peoples R China Peking Union Med Coll Hosp, Dept Hematol, Beijing, Peoples R China Univ Sci & Technol China, Dept Hematol, Affiliated Hosp 1, Hefei, Peoples R China InnoCare Pharm Ltd, Dept Clin Dev, Tongji Med Coll, Dept Hematol, Beijing, Peoples R China First Hosp Jilin Univ, Dept Hematol, Jilin, Peoples R China Xiamen Univ, Dept Hematol, Affiliated Hosp 1, Xiamen, Peoples R China Henan Prov Peoples Hosp, Inst Hematol, Zhengzhou, Peoples R China Sichuan Univ, Dept Hematol, West China Hosp, Chengdu, Peoples R China Tianjin Med Univ Canc Inst & Hosp, Lymphoma, Tianjin, Peoples R China Fujian Med Univ, Fujian Inst Hematol, Dept Hematol, Fujian Prov Key Lab Hematol,Union Hosp, Fuzhou, Peoples R China Shandong Univ Jinan, Qilu Hosp, Dept Hematol, Jinan, Peoples R China Guangzhou First Peoples Hosp, Dept Hematol, Guangzhou, Peoples R China Sun Yatsen Univ, Collaborat Innovat Ctr Canc Med, Dept Hematol Oncol, State Key Lab Oncol South China,Canc Ctr, Guangzhou, Peoples R China Shandong Prov Hosp, Dept Hematol, Jinan, Peoples R China China Med Univ, Dept Hematol, Affiliated Hosp 1, Shenyang, Peoples R China |
| Keywords | ACALABRUTINIB ACP-196 ATRIAL-FIBRILLATION IBRUTINIB CLL COLLAGEN RISK |
| Issue Date | Jan-2023 |
| Publisher | AMERICAN JOURNAL OF HEMATOLOGY |
| Abstract | 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. |
| URI | http://hdl.handle.net/20.500.11897/670185 |
| ISSN | 0361-8609 |
| DOI | 10.1002/ajh.26826 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
