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Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE
JR. Brown, B. Eichhorst, N. Lamanna, SM. O'Brien, CS. Tam, L. Qiu, W. Jurczak, K. Zhou, M. Šimkovič, J. Mayer, A. Gillespie-Twardy, A. Ferrajoli, PS. Ganly, R. Weinkove, S. Grosicki, A. Mital, T. Robak, A. Osterborg, HA. Yimer, M. Wang, T. Salmi,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, srovnávací studie, randomizované kontrolované studie, multicentrická studie, klinické zkoušky, fáze III
NLK
Free Medical Journals
od 1946 do Před 1 rokem
Freely Accessible Science Journals
od 1946 do Před 1 rokem
Open Access Digital Library
od 1946-01-01
Open Access Digital Library
od 1946-01-01
ROAD: Directory of Open Access Scholarly Resources
PubMed
39316666
DOI
10.1182/blood.2024024667
Knihovny.cz E-zdroje
- MeSH
- adenin * analogy a deriváty terapeutické užití MeSH
- chronická lymfatická leukemie * farmakoterapie mortalita MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- piperidiny * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- pyrazoly * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- pyrimidiny * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
The ALPINE trial established the superiority of zanubrutinib over ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma; here, we present data from the final comparative analysis with extended follow-up. Overall, 652 patients received zanubrutinib (n = 327) or ibrutinib (n = 325). At an overall median follow-up of 42.5 months, progression-free survival benefit with zanubrutinib vs ibrutinib was sustained (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.54-0.84), including in patients with del(17p)/TP53 mutation (HR, 0.51; 95% CI, 0.33-0.78) and across multiple sensitivity analyses. Overall response rate remained higher with zanubrutinib compared with ibrutinib (85.6% vs 75.4%); responses deepened over time with complete response/complete response with incomplete bone marrow recovery rates of 11.6% (zanubrutinib) and 7.7% (ibrutinib). Although median overall survival has not been reached in either treatment group, fewer zanubrutinib patients have died than ibrutinib patients (HR, 0.77 [95% CI, 0.55-1.06]). With median exposure time of 41.2 and 37.8 months in zanubrutinib and ibrutinib arms, respectively, the most common nonhematologic adverse events included COVID-19-related infection (46.0% vs 33.3%), diarrhea (18.8% vs 25.6%), upper respiratory tract infection (29.3% vs 19.8%), and hypertension (27.2% vs 25.3%). Cardiac events were lower with zanubrutinib (25.9% vs 35.5%) despite similar rates of hypertension. Incidence of atrial fibrillation/flutter was lower with zanubrutinib vs ibrutinib (7.1% vs 17.0%); no cardiac deaths were reported with zanubrutinib vs 6 cardiac deaths with ibrutinib. This analysis, at 42.5 months median follow-up, demonstrates that zanubrutinib remains more efficacious than ibrutinib with an improved overall safety/tolerability profile. This trial was registered at www.ClinicalTrials.gov as #NCT03734016.
Cancer Immunotherapy Programme Malaghan Institute of Medical Research Wellington New Zealand
Clinical Development BeiGene Co Ltd Beijing China
Clinical Development BeiGene International GmbH Basel Switzerland
Clinical Development BeiGene USA Inc San Mateo CA
Clinical Research Division Fred Hutchinson Cancer Center Seattle WA
Department of Haematology Christchurch Hospital Christchurch New Zealand
Department of Haematology Monash University Melbourne VIC Australia
Department of Haematology The Alfred Hospital Melbourne VIC Australia
Department of Hematology and Medical Oncology Texas Oncology Tyler US Oncology Research Tyler TX
Department of Hematology and Transplantology Medical University of Gdańsk Gdańsk Poland
Department of Hematology Karolinska University Hospital Stockholm Sweden
Department of Hematology Medical University of Lodz Lodz Poland
Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX
Department of Medical Oncology Dana Farber Cancer Institute Boston MA
Department of Medicine University of Washington Seattle WA
Department of Oncology Pathology Karolinska Institutet Stockholm Sweden
Medical Oncology and Hematology Blue Ridge Cancer Care Roanoke VA
Citace poskytuje Crossref.org
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