Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib v...
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| Veröffentlicht in: | Annals of hematology 2024-10, Vol.103 (10), p.4183-4191 |
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| creator | Zhou, Keshu Wang, Tingyu Pan, Ling Xu, Wei Jin, Jie Zhang, Wei Hu, Yu Hu, Jianda Feng, Ru Li, Ping Liu, Zhougang Liu, Peng Jing, Hongmei Gao, Sujun Zhang, Huilai Yu, Kang Wang, Zhao Zhu, Xiongpeng Sun, Zimin Li, Fei Yan, Dongmei Weng, Jianyu Fu, Lina Wang, Liping Salmi, Tommi Wu, Kenneth Qiu, Lugui |
| description | Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib vs. ibrutinib to treat relapsed/refractory (R/R) CLL/SLL. Here we report results from the subgroup of Chinese patients. Adults with R/R CLL/SLL were randomized 1:1 to receive zanubrutinib (160 mg twice-daily) or ibrutinib (420 mg once-daily) until disease progression or unacceptable toxicity. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Data were analyzed descriptively. Ninety patients were randomized in China (zanubrutinib,
n
= 47; ibrutinib,
n
= 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (
TP53
) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018. |
| doi_str_mv | 10.1007/s00277-024-05823-8 |
| format | Article |
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n
= 47; ibrutinib,
n
= 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (
TP53
) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018.</description><identifier>ISSN: 0939-5555</identifier><identifier>ISSN: 1432-0584</identifier><identifier>EISSN: 1432-0584</identifier><identifier>DOI: 10.1007/s00277-024-05823-8</identifier><identifier>PMID: 38888616</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adenine - analogs & derivatives ; Adenine - therapeutic use ; Adult ; Agammaglobulinaemia Tyrosine Kinase - antagonists & inhibitors ; Aged ; Aged, 80 and over ; China - epidemiology ; Drug Resistance, Neoplasm ; Female ; Hematology ; Humans ; Inhibitor drugs ; Kinases ; Leukemia ; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell - mortality ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Piperidines - adverse effects ; Piperidines - therapeutic use ; Progression-Free Survival ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use ; Pyrazoles - administration & dosage ; Pyrazoles - adverse effects ; Pyrazoles - therapeutic use ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Pyrimidines - therapeutic use ; Targeted cancer therapy ; Treatment Outcome</subject><ispartof>Annals of hematology, 2024-10, Vol.103 (10), p.4183-4191</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c356t-36df3c7cb59e13a1ba2a09581df0617e168ba3fa412551cdc759e076cfd064e23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00277-024-05823-8$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00277-024-05823-8$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,778,782,883,27913,27914,41477,42546,51308</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38888616$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhou, Keshu</creatorcontrib><creatorcontrib>Wang, Tingyu</creatorcontrib><creatorcontrib>Pan, Ling</creatorcontrib><creatorcontrib>Xu, Wei</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Zhang, Wei</creatorcontrib><creatorcontrib>Hu, Yu</creatorcontrib><creatorcontrib>Hu, Jianda</creatorcontrib><creatorcontrib>Feng, Ru</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Liu, Zhougang</creatorcontrib><creatorcontrib>Liu, Peng</creatorcontrib><creatorcontrib>Jing, Hongmei</creatorcontrib><creatorcontrib>Gao, Sujun</creatorcontrib><creatorcontrib>Zhang, Huilai</creatorcontrib><creatorcontrib>Yu, Kang</creatorcontrib><creatorcontrib>Wang, Zhao</creatorcontrib><creatorcontrib>Zhu, Xiongpeng</creatorcontrib><creatorcontrib>Sun, Zimin</creatorcontrib><creatorcontrib>Li, Fei</creatorcontrib><creatorcontrib>Yan, Dongmei</creatorcontrib><creatorcontrib>Weng, Jianyu</creatorcontrib><creatorcontrib>Fu, Lina</creatorcontrib><creatorcontrib>Wang, Liping</creatorcontrib><creatorcontrib>Salmi, Tommi</creatorcontrib><creatorcontrib>Wu, Kenneth</creatorcontrib><creatorcontrib>Qiu, Lugui</creatorcontrib><title>Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE</title><title>Annals of hematology</title><addtitle>Ann Hematol</addtitle><addtitle>Ann Hematol</addtitle><description>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib vs. ibrutinib to treat relapsed/refractory (R/R) CLL/SLL. Here we report results from the subgroup of Chinese patients. Adults with R/R CLL/SLL were randomized 1:1 to receive zanubrutinib (160 mg twice-daily) or ibrutinib (420 mg once-daily) until disease progression or unacceptable toxicity. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Data were analyzed descriptively. Ninety patients were randomized in China (zanubrutinib,
n
= 47; ibrutinib,
n
= 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (
TP53
) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018.</description><subject>Adenine - analogs & derivatives</subject><subject>Adenine - therapeutic use</subject><subject>Adult</subject><subject>Agammaglobulinaemia Tyrosine Kinase - antagonists & inhibitors</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>China - epidemiology</subject><subject>Drug Resistance, Neoplasm</subject><subject>Female</subject><subject>Hematology</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Kinases</subject><subject>Leukemia</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - mortality</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Piperidines - adverse effects</subject><subject>Piperidines - therapeutic use</subject><subject>Progression-Free Survival</subject><subject>Protein Kinase Inhibitors - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhou, Keshu</au><au>Wang, Tingyu</au><au>Pan, Ling</au><au>Xu, Wei</au><au>Jin, Jie</au><au>Zhang, Wei</au><au>Hu, Yu</au><au>Hu, Jianda</au><au>Feng, Ru</au><au>Li, Ping</au><au>Liu, Zhougang</au><au>Liu, Peng</au><au>Jing, Hongmei</au><au>Gao, Sujun</au><au>Zhang, Huilai</au><au>Yu, Kang</au><au>Wang, Zhao</au><au>Zhu, Xiongpeng</au><au>Sun, Zimin</au><au>Li, Fei</au><au>Yan, Dongmei</au><au>Weng, Jianyu</au><au>Fu, Lina</au><au>Wang, Liping</au><au>Salmi, Tommi</au><au>Wu, Kenneth</au><au>Qiu, Lugui</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE</atitle><jtitle>Annals of hematology</jtitle><stitle>Ann Hematol</stitle><addtitle>Ann Hematol</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>103</volume><issue>10</issue><spage>4183</spage><epage>4191</epage><pages>4183-4191</pages><issn>0939-5555</issn><issn>1432-0584</issn><eissn>1432-0584</eissn><abstract>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib vs. ibrutinib to treat relapsed/refractory (R/R) CLL/SLL. Here we report results from the subgroup of Chinese patients. Adults with R/R CLL/SLL were randomized 1:1 to receive zanubrutinib (160 mg twice-daily) or ibrutinib (420 mg once-daily) until disease progression or unacceptable toxicity. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Data were analyzed descriptively. Ninety patients were randomized in China (zanubrutinib,
n
= 47; ibrutinib,
n
= 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (
TP53
) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>38888616</pmid><doi>10.1007/s00277-024-05823-8</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0939-5555 |
| ispartof | Annals of hematology, 2024-10, Vol.103 (10), p.4183-4191 |
| issn | 0939-5555 1432-0584 1432-0584 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11512864 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adenine - analogs & derivatives Adenine - therapeutic use Adult Agammaglobulinaemia Tyrosine Kinase - antagonists & inhibitors Aged Aged, 80 and over China - epidemiology Drug Resistance, Neoplasm Female Hematology Humans Inhibitor drugs Kinases Leukemia Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemia, Lymphocytic, Chronic, B-Cell - mortality Male Medicine Medicine & Public Health Middle Aged Oncology Piperidines - adverse effects Piperidines - therapeutic use Progression-Free Survival Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrazoles - administration & dosage Pyrazoles - adverse effects Pyrazoles - therapeutic use Pyrimidines - administration & dosage Pyrimidines - adverse effects Pyrimidines - therapeutic use Targeted cancer therapy Treatment Outcome |
| title | Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-15T09%3A42%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Improved%20efficacy%20and%20safety%20of%20zanubrutinib%20versus%20ibrutinib%20in%20patients%20with%20relapsed/refractory%20chronic%20lymphocytic%20leukemia%20(R/R%20CLL)%20in%20China:%20a%20subgroup%20of%20ALPINE&rft.jtitle=Annals%20of%20hematology&rft.au=Zhou,%20Keshu&rft.date=2024-10-01&rft.volume=103&rft.issue=10&rft.spage=4183&rft.epage=4191&rft.pages=4183-4191&rft.issn=0939-5555&rft.eissn=1432-0584&rft_id=info:doi/10.1007/s00277-024-05823-8&rft_dat=%3Cproquest_pubme%3E3121050269%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3121050269&rft_id=info:pmid/38888616&rfr_iscdi=true |