FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL

Caroline Dartigeas, Borhane Slama, Margaret Doyle, Christoph Tapprich, Claire Albrecht, Sandrine Dupuis, Robert Wapenaar, Charlotte Schmidt-Hieber, Veronique Leblond, Caroline Dartigeas, Borhane Slama, Margaret Doyle, Christoph Tapprich, Claire Albrecht, Sandrine Dupuis, Robert Wapenaar, Charlotte Schmidt-Hieber, Veronique Leblond

Abstract

The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. First-line CLL/SLL patients had del17p and/or TP53 mutations. In this interim analysis, the median follow-up time for patients with CLL/SLL and MCL was 17.7 and 15.1 months, respectively. In the effectiveness populations for CLL/SLL (n = 200) and MCL (n = 59), the median progression-free survival was not estimable and 12.4 months, respectively; the 12-month overall survival rates were 88.5% and 65.8%, respectively. Treatment-emergent adverse events of interest for patients with CLL/SLL (n = 202) and MCL (n = 59) included: infections and infestations (53.5% and 32.2%), major bleeding (5.0% and 5.1%), and atrial fibrillation (5.9% and 8.5%); 135 (66.8%) and 20 (33.9%) patients were continuing treatment at the time of data cutoff. Future analyses will report on longer-term follow-up (Trial registration: ClinicalTrials.gov, NCT03425591. Registered 1 February 2018-Retrospectively registered, https://ichgcp.net/clinical-trials-registry/NCT03425591 ).

Keywords: Chronic lymphocytic leukemia; Effectiveness; Ibrutinib; Mantle cell lymphoma; Real-world evidence; Safety.

Conflict of interest statement

CD served on AbbVie, AstraZeneca, BeiGene, and Janssen advisory boards, and received travel grants from AbbVie, AstraZeneca, and Janssen. MD, CT, CA, and RW are employees of Janssen and report stock ownership of Johnson & Johnson. SD is an employee of Janssen. VL has received honoraria from AbbVie, Amgen, BeiGene, Gilead, Janssen, and Roche, and consultancy fees from AbbVie, AstraZeneca, BeiGene, Ely Lilly, Gilead, and Janssen, and research funding from AbbVie, Janssen, and Roche. BS and CS-H have nothing to disclose.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Impact of ibrutinib on PFS in patients with CLL/SLL (A) and patients with MCL (B). CI confidence interval; CLL chronic lymphocytic leukemia; MCL mantle cell lymphoma; mo month; NE not estimable; PFS progression-free survival; SLL small lymphocytic lymphoma
Fig. 2
Fig. 2
Impact of ibrutinib on OS in patients with CLL/SLL (A) and patients with MCL (B). CI confidence interval; CLL chronic lymphocytic leukemia; MCL mantle cell lymphoma; mo month, NE not estimable; OS overall survival; SLL small lymphocytic lymphoma

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