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. Issue 3 (14th July 2021)

• Record Type: Journal Article
• Authors: Lundin, Jeanette; Mulder, Tom A.; Kättström, Magdalena; Wästerlid, Tove; Uddevik, Anders; Mellstedt, Håkan; Heimersson, Kia; Hansson, Lotta; Palma, Marzia; Österborg, Anders
• Is Part Of: EJHaem. Volume 2:Issue 3(2021)
• Page Start: 525
• Page End: 529
• Publication Date: 2021-07-14
• Subjects: Hematology -- Periodicals; 616.15
• DOI: 10.1002/jha2.261
• Languages: English
• ISSNs: 2688-6146

Abstract

Abstract: 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.