Outcomes with ibrutinib in patients with chronic lymphocytic leukaemia: Results from the German multicentre REALITY study

Abstract

AbstractObjectivesTo assess treatment adherence, effectiveness and safety outcomes of patients with chronic lymphocytic leukaemia (CLL) receiving ibrutinib in a real‐world setting.MethodsPatients enrolled in REALITY were ≥18 years with a confirmed diagnosis of CLL and were receiving ibrutinib as a first‐line (1L), 2L or ≥3L therapy. Treatment retention, adherence, progression‐free survival (PFS), overall survival (OS) and time to next therapy were assessed at 1 and 2 years overall, by typology and by cytogenetic subgroups. PFS and OS were analysed using Kaplan–Meier methods.ResultsExactly 302 patients were enrolled across 57 sites in Germany, from January 2017 to July 2021. One‐year retention rates were 69.9% overall (primary endpoint), 77.9% for 1L patients, and 77.6%/78.8% for high‐risk patients with del17p/TP53. At 2 years, PFS/OS rates were 77.8%/90.7% overall (1L, 82.7%/90.4%), and were consistent across cytogenetic subgroups. PFS rates were higher for 1L versus ≥3L patients. Patients with the low‐acceptance/low‐control typology at baseline were less likely to retain treatment at 1 year versus the high‐acceptance/high‐control typology. No new safety signals were observed.ConclusionsThe REALITY study provides further evidence of the effectiveness and safety of ibrutinib in patients with CLL in a real‐world setting, particularly in earlier treatment lines.