Detailed safety profile of acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia in the ELEVATE-RR trial

Seymour et al. performed a post hoc analysis of ELEVATE-RR data to further characterize adverse events (AEs) associated with acalabrutinib vs. AEs associated with ibrutinib. A total of 529 patients were included: 266 received acalabrutinib, and 263 received ibrutinib. The most common AEs—diarrhea, arthralgia, urinary tract infection, back pain, muscle spasm, and dyspepsia—were more frequent with ibrutinib, with 1.5- to 4.1-fold higher exposure-adjusted incidence rates. Although incidences of overall cardiac events were similar between arms, incidences of any-grade atrial fibrillation/flutter, hypertension, and bleeding were increased with ibrutinib (exposure-adjusted incidence rates: 2.0-, 2.8-, and 1.6-fold, respectively). Incidences of infection rates also were similar between arms. The rate of discontinuation was found to be lower for acalabrutinib (HR, 0.62; 95% CI: 0.41-0.93).