ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

RCT (n=398) found that acalabrutinib monotherapy significantly improved progression-free survival (PFS) compared with investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab (PFS not reached vs 16.5 months, HR 0.31; 95% CI, 0.20 to 0.49, p <0.0001).

SPS commentary:

Acalabrutinib is a second-generation selective Bruton's tyrosine kinase (Btk) inhibitor. It is approved in US for the treatment of chronic lymphocytic leukaemia based on the ASCEND study and the ELEVATE-TN study (combination therapy with obinutuzumab or monotherapy of previously untreated patients). It was filed for approval in EU in November 2019.

American Society of Clinical Oncology