First-Line Ibrutinib Plus Venetoclax in MCL for Older Patients or Those with a TP53 Mutation: Ongoing Open-Label Arm of the PCYC-1143 Phase 3 SYMPATICO Study

Abstract

Context: Ibrutinib, a once-daily inhibitor of Bruton tyrosine kinase (BTK), is approved in the US for patients with MCL with ≥1 prior therapy. Single-agent ibrutinib received accelerated approval for MCL after showing complete response (CR) rates of 19–21% and overall response rates of 68–72% (Dreyling Lancet 2016; Wang NEJM 2013). Venetoclax is a BCL2 inhibitor approved in the US for patients with CLL with ≥1 prior therapy and for patients with previously untreated AML. Single-agent venetoclax has also shown efficacy in MCL, with CR rates of 21% (Davids J Clin Oncol 2017). In preclinical models, ibrutinib + venetoclax showed synergistic antitumor activity via dual inhibition of the BTK and ..