Key clinical point : Compared with fludarabine, cyclophosphamide, and rituximab, ibrutinib and rituximab provided a significant progression-free survival (PFS) benefit in treatment-naive patients with chronic lymphocytic leukemia (CLL).
Major finding: After a median follow-up of 53 months, the median PFS was not reached in patients receiving ibrutinib and rituximab and was 67 months (95% CI 63-not reached) in those receiving fludarabine, cyclophosphamide, and rituximab (hazard ratio 0.44; P < .0001). A substantial number of sudden cardiac or unexplained deaths occurred, which were more frequent in the ibrutinib and rituximab group.
Study details: This interim analysis of the multicenter phase 3 FLAIR trial included 771 treatment-naive adult patients with CLL or small lymphocytic lymphoma who were randomly assigned to receive ibrutinib and rituximab (n = 386) or fludarabine, cyclophosphamide, and rituximab (n = 385).
Disclosures: This study was funded by Cancer Research UK, Janssen, and others. Some authors declared participating on data safety monitoring or advisory boards and receiving grants, personal consulting or speaker fees, lecture honoraria, or travel support from the study funders and others.
Source: Hillmen P et al. Ibrutinib and rituximab versus fludarabine, cyclophosphamide, and rituximab for patients with previously untreated chronic lymphocytic leukaemia (FLAIR): Interim analysis of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(5):535-552 (May). Doi: 10.1016/S1470-2045(23)00144-4