Shanafelt TD, Wang XV, Kay NK, et al. – In this phase 3 trial involving 529 patients, researchers determined the efficacy of ibrutinib–rituximab treatment vs a standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab in patients with previously untreated chronic lymphocytic leukemia (CLL). Overall, the outcomes of the analysis of progression-free survival (PFS) and overall survival supported ibrutinib–rituximab over chemoimmunotherapy, and it also met the protocol-defined efficiency threshold for the interim analysis, at a median follow-up of 33.6 months. In addition, ibrutinib–rituximab led to better PFS vs chemoimmunotherapy in patients without immunoglobulin heavy-chain variable region (IGHV) mutation. Among patients with IGHV mutation, the 3-year PFS was 87.7% and 88.0% in the ibrutinib–rituximab and chemoimmunotherapy groups, respectively. In the two groups, the incidence of adverse events of grade 3 or higher (regardless of attribution) was comparable, whereas infectious complications of grade 3 or higher were less prevalent with ibrutinib–rituximab vs chemoimmunotherapy. Therefore, among patients aged 70 years or younger with formerly untreated CLL, the ibrutinib–rituximab regimen led to PFS and overall survival outcomes that were higher vs a standard chemoimmunotherapy regimen.