Temporary cessation of ibrutinib results in reduced grade 3‐4 infections and durable remissions—Interim analysis of an on‐off‐repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia

Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on‐off‐repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off‐phase irrespective if initial CR/PR or TP53 aberration. Grade 3‐4 infections were reduced from 55% to 5% during...

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Detalles Bibliográficos
Autores principales: Lundin, Jeanette, Mulder, Tom A., Kättström, Magdalena, Wästerlid, Tove, Uddevik, Anders, Mellstedt, Håkan, Heimersson, Kia, Hansson, Lotta, Palma, Marzia, Österborg, Anders
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Short Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9176042/
https://www.ncbi.nlm.nih.gov/pubmed/35844699
http://dx.doi.org/10.1002/jha2.261
Descripción
Sumario:Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on‐off‐repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off‐phase irrespective if initial CR/PR or TP53 aberration. Grade 3‐4 infections were reduced from 55% to 5% during a similarly long off‐phase (P < .01). Treg and exhausted T‐cells increased (P = .01). Six patients restarted ibrutinib at early progression and remain drug‐sensitive. Our interim analysis shows a durable off‐phase in most patients, with reduced infections and cost‐saving potential. If toxicity‐driven permanent cessation of ibrutinib will be affected will be explored in the extended study.

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