Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL : primary analysis of the CAPTIVATE FD cohort
Tam, Constantine S. (University of Melbourne)
Allan, John N. (Weill Cornell Medicine)
Siddiqi, Tanya (City of Hope National Medical Center (Duarte, Estats Units d'Amèrica))
Kipps, Thomas J. (University of California San Diego)
Jacobs, Ryan (Levine Cancer Institute)
Opat, Stephen (Monash University)
Barr, Paul M. (University of Rochester Medical Center)
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda)
Trentin, Livio (University of Padova)
Bannerji, Rajat (Rutgers Cancer Institute of New Jersey)
Jackson, Sharon (Middlemore Hospital)
Kuss, Bryone J. (Flinders University. Medical Centre)
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau)
Szafer-Glusman, Edith (Pharmacyclics LLC. an AbbVie Company)
Russell, Kristin (Pharmacyclics LLC. an AbbVie Company)
Zhou, Cathy (Pharmacyclics LLC. an AbbVie Company)
Ninomoto, Joi (Pharmacyclics LLC. an AbbVie Company)
Dean, James P. (Pharmacyclics LLC. an AbbVie Company)
Wierda, William G. (DepaUniversity of Texas MD Anderson Cancer Center)
Ghia, Paolo (IRCCS Ospedale San Raffaele (Milà, Itàlia))
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	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.
Rights:	Aquest 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.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Blood, Vol. 139 Núm. 22 (february 2022) , p. 3278-3289, ISSN 1528-0020

DOI: 10.1182/blood.2021014488
PMID: 35196370

12 p, 1.1 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
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