Acalabrutinib meets primary endpoint in ELEVATE-RR trial for patients with R/R CLL

On January 25, 2021, it was announced that acalabrutinib has met its primary endpoint of non-inferior progression-free survival compared with ibrutinib in the ELEVATE-RR trial of adults with relapsed/refractory, high-risk chronic lymphocytic leukemia (CLL).¹

The phase III trial is the first to compare two Bruton’s tyrosine kinase inhibitors in CLL, and has also met a secondary endpoint for safety, showing a significantly lower incidence of atrial fibrillation compared with patients treated with ibrutinib.¹

ELEVATE-RR (NCT02477696) is a multicenter, open label, phase III non-inferiority study of acalabrutinib vs ibrutinib in patients with previously treated high-risk CLL (presence of 17p and/or 11q deletion). The primary endpoint was progression-free survival. Secondary endpoints were incidence of treatment-emergent Grade ≥ 3 infections, incidence of Richter’s transformation, incidence of atrial fibrillation, and overall survival.

Acalabrutinib is approved in the U.S. and Europe for the treatment of adult patients with CLL. The ELEVATE-RR trial data is to be presented at an upcoming medical meeting and shared with health authorities.