First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia.
John C Byrd, Peter Hillmen, Paolo Ghia, Arnon P Kater, Asher Alban Akmal Chanan-Khan, Richard R Furman, Susan M O'Brien, Mustafa Nuri Yenerel, Árpád Illés, Neil E Kay, Jose Antonio Garcia Marco, Anthony R Mato, John Francis Seymour, Stephane Leprêtre, Stephan Stilgenbauer, Tadeusz Robak, Priti Patel, Kara Higgins, Sophia Sohoni, Wojciech Jurczak
Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2021
7500 Background: Increased selectivity of the Bruton tyrosine kinase inhibitor (BTKi) acalabrutinib (Aca) vs ibrutinib (Ib) may improve tolerability. We conducted an open-label, randomized, noninferiority, phase 3 trial to compare Aca vs Ib in patients (pts) with chronic lymphocytic leukemia (CLL). Methods: Previously treated CLL pts with del(17p) or del(11q) by central lab were randomized to receive oral Aca 100 mg BID or Ib 420 mg QD (stratified by del(17p) status, ECOG PS [2 vs ≤1], and number of prior therapies [1–3 vs ≥4]) until progression or unacceptable toxicity. Primary endpoint was progression-free survival (PFS) as assessed by IRC; secondary endpoints of all grade atrial fibrilla..View full abstract