Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL

CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib...

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Autores: Tam, Constantine S.|||0000-0002-9759-5017, Allan, John N.|||0000-0002-2088-0899, Siddiqi, Tanya|||0000-0001-5292-8298, Kipps, Thomas J.|||0000-0002-0064-4549, Jacobs, Ryan, Opat, Stephen, Barr, Paul M.|||0000-0002-9733-401X, Tedeschi, Alessandra, Trentin, Livio|||0000-0003-1222-6149, Bannerji, Rajat, Jackson, Sharon|||0000-0003-3584-8872, Kuss, Bryone J., Moreno, Carol|||0000-0003-3275-0271, Szafer-Glusman, Edith, Russell, Kristin, Zhou, Cathy, Ninomoto, Joi, Dean, James P., Wierda, William G., Ghia, Paolo|||0000-0003-3750-7342
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:290532
Acceso en línea:https://ddd.uab.cat/record/290532
https://dx.doi.org/urn:doi:10.1182/blood.2021014488
Access Level:acceso abierto
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spelling Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLLprimary analysis of the CAPTIVATE FD cohortTam, Constantine S.|||0000-0002-9759-5017Allan, John N.|||0000-0002-2088-0899Siddiqi, Tanya|||0000-0001-5292-8298Kipps, Thomas J.|||0000-0002-0064-4549Jacobs, RyanOpat, StephenBarr, Paul M.|||0000-0002-9733-401XTedeschi, AlessandraTrentin, Livio|||0000-0003-1222-6149Bannerji, RajatJackson, Sharon|||0000-0003-3584-8872Kuss, Bryone J.Moreno, Carol|||0000-0003-3275-0271Szafer-Glusman, EdithRussell, KristinZhou, CathyNinomoto, JoiDean, James P.Wierda, William G.Ghia, Paolo|||0000-0003-3750-7342CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib lead-in then 12 cycles of ibrutinib plus venetoclax (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing was performed for patients without del(17p) with prespecified analyses in all treated patients. Secondary endpoints included undetectable minimal residual disease (uMRD) rates, progression-free survival (PFS), overall survival (OS), and safety. Of the 159 patients enrolled and treated, 136 were without del(17p). The median time on study was 27.9 months, and 92% of patients completed all planned treatment. The primary endpoint was met, with a CR rate of 56% (95% confidence interval [CI], 48-64) in patients without del(17p), significantly higher than the prespecified 37% minimum rate (P <.0001). In the all-treated population, CR rate was 55% (95% CI, 48-63); best uMRD rates were 77% (peripheral blood [PB]) and 60% (bone marrow [BM]); 24-month PFS and OS rates were 95% and 98%, respectively. At baseline, 21% of patients were in the high tumor burden category for tumor lysis syndrome (TLS) risk; after ibrutinib lead-in, only 1% remained in this category. The most common grade ≥3 adverse events (AEs) were neutropenia (33%) and hypertension (6%). First-line ibrutinib plus venetoclax represents the first all-oral, once-daily, chemotherapy-free FD regimen for patients with CLL. FD ibrutinib plus venetoclax achieved deep, durable responses and promising PFS, including in patients with high-risk features.Universitat Autònoma de Barcelona 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/290532https://dx.doi.org/urn:doi:10.1182/blood.2021014488reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2905322026-06-06T12:50:31Z
dc.title.none.fl_str_mv Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
primary analysis of the CAPTIVATE FD cohort
title Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
spellingShingle Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
Tam, Constantine S.|||0000-0002-9759-5017
title_short Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
title_full Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
title_fullStr Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
title_full_unstemmed Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
title_sort Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL
dc.creator.none.fl_str_mv Tam, Constantine S.|||0000-0002-9759-5017
Allan, John N.|||0000-0002-2088-0899
Siddiqi, Tanya|||0000-0001-5292-8298
Kipps, Thomas J.|||0000-0002-0064-4549
Jacobs, Ryan
Opat, Stephen
Barr, Paul M.|||0000-0002-9733-401X
Tedeschi, Alessandra
Trentin, Livio|||0000-0003-1222-6149
Bannerji, Rajat
Jackson, Sharon|||0000-0003-3584-8872
Kuss, Bryone J.
Moreno, Carol|||0000-0003-3275-0271
Szafer-Glusman, Edith
Russell, Kristin
Zhou, Cathy
Ninomoto, Joi
Dean, James P.
Wierda, William G.
Ghia, Paolo|||0000-0003-3750-7342
author Tam, Constantine S.|||0000-0002-9759-5017
author_facet Tam, Constantine S.|||0000-0002-9759-5017
Allan, John N.|||0000-0002-2088-0899
Siddiqi, Tanya|||0000-0001-5292-8298
Kipps, Thomas J.|||0000-0002-0064-4549
Jacobs, Ryan
Opat, Stephen
Barr, Paul M.|||0000-0002-9733-401X
Tedeschi, Alessandra
Trentin, Livio|||0000-0003-1222-6149
Bannerji, Rajat
Jackson, Sharon|||0000-0003-3584-8872
Kuss, Bryone J.
Moreno, Carol|||0000-0003-3275-0271
Szafer-Glusman, Edith
Russell, Kristin
Zhou, Cathy
Ninomoto, Joi
Dean, James P.
Wierda, William G.
Ghia, Paolo|||0000-0003-3750-7342
author_role author
author2 Allan, John N.|||0000-0002-2088-0899
Siddiqi, Tanya|||0000-0001-5292-8298
Kipps, Thomas J.|||0000-0002-0064-4549
Jacobs, Ryan
Opat, Stephen
Barr, Paul M.|||0000-0002-9733-401X
Tedeschi, Alessandra
Trentin, Livio|||0000-0003-1222-6149
Bannerji, Rajat
Jackson, Sharon|||0000-0003-3584-8872
Kuss, Bryone J.
Moreno, Carol|||0000-0003-3275-0271
Szafer-Glusman, Edith
Russell, Kristin
Zhou, Cathy
Ninomoto, Joi
Dean, James P.
Wierda, William G.
Ghia, Paolo|||0000-0003-3750-7342
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
description CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib lead-in then 12 cycles of ibrutinib plus venetoclax (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing was performed for patients without del(17p) with prespecified analyses in all treated patients. Secondary endpoints included undetectable minimal residual disease (uMRD) rates, progression-free survival (PFS), overall survival (OS), and safety. Of the 159 patients enrolled and treated, 136 were without del(17p). The median time on study was 27.9 months, and 92% of patients completed all planned treatment. The primary endpoint was met, with a CR rate of 56% (95% confidence interval [CI], 48-64) in patients without del(17p), significantly higher than the prespecified 37% minimum rate (P <.0001). In the all-treated population, CR rate was 55% (95% CI, 48-63); best uMRD rates were 77% (peripheral blood [PB]) and 60% (bone marrow [BM]); 24-month PFS and OS rates were 95% and 98%, respectively. At baseline, 21% of patients were in the high tumor burden category for tumor lysis syndrome (TLS) risk; after ibrutinib lead-in, only 1% remained in this category. The most common grade ≥3 adverse events (AEs) were neutropenia (33%) and hypertension (6%). First-line ibrutinib plus venetoclax represents the first all-oral, once-daily, chemotherapy-free FD regimen for patients with CLL. FD ibrutinib plus venetoclax achieved deep, durable responses and promising PFS, including in patients with high-risk features.
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/290532
https://dx.doi.org/urn:doi:10.1182/blood.2021014488
url https://ddd.uab.cat/record/290532
https://dx.doi.org/urn:doi:10.1182/blood.2021014488
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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