Highlights from

EHA 2019

European Hematology Association

Amsterdam 13-16 June 2019

ASCEND study: Acalabrutinib improves progression-free survival in relapsed/refractory CLL

Dr Paolo Ghia (Vita-Salute San Raffaele University, Italy) presented the findings from the phase 3 ASCEND study of the Bruton’s tyrosine Kinase inhibitor (BTKi) acalabrutinib in relapsed or refractory chronic lymphocytic leukaemia (CLL). The study demonstrated that acalabrutinib had superior progression-free survival vs rituximab with idelalisib or bendamustine [1].

The ASCEND trial was a global, multicentre, open-label, phase 3 study that randomised 310 patients to receive either acalabrutinib monotherapy or the physician’s choice of either idelalisib plus rituximab or bendamustine.. Acalabrutinib is a highly selective, potent inhibitor of BTK that has previously demonstrated substantial activity and improved tolerability in patients with CLL, similar to ibrutinib. In this study, acalabrutinib monotherapy significantly improved progression-free survival, with a more tolerable safety profile, compared with idelalisib plus rituximab or bendamustine in patients with relapsed or refractory CLL, reducing the risk of disease progression or death by 69% at a median follow-up of 16.1 months (HR 0.31; 95% CI 0.20-0.49, P<0.0001). At 12 months, 88% of patients on acalabrutinib showed no disease progression compared with 68% for the control arm, with tolerability consistent with the known profile.

These results are significant because there is a need for an effective but also well-tolerated BTKi for patients with CLL. In addition, no new safety signals were identified for acalabrutinib. The ASCEND study results indicate that acalabrutinib has the potential to change current practice by providing a well-tolerated, highly effective BTKi treatment option.

Dr Ghia concluded: “This is the first randomised study to directly compare a BTK inhibitor as monotherapy with standard chemoimmunotherapy or idelalisib and rituximab combinations. With a significant improvement in progression-free survival and a favourable safety profile, acalabrutinib may become an important choice for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia.”

  1. Ghia P, et al. LB2601, 24th Congress of the EHA, 13-16 June 2019, Amsterdam, the Netherlands.

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