Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial
In this RCT (n=535), median progression-free survival was longer with acalabrutinib-obinutuzumab (A-O) and acalabrutinib monotherapy (A) than with obinutuzumab-chlorambucil (O-C) (not reached with A-O or A at median follow-up of 28.3 months vs 22.6 months with O-C; both p<0.0001)
Source:
The Lancet
SPS commentary:
A related comment notes that several novel agents have been approved for CLL over the past few years, including ibrutinib, an oral small molecule inhibitor targeting Bruton tyrosine kinase (BTK), a key protein in CLL cells. Acalabrutinib is a more selective BTK inhibitor than ibrutinib, and the current study is the first Phase III trial of its use in the first-line setting, leading to its approval in the US (it has yet to be approved in the EU/UK). The authors note that although the results substantiate the promising efficacy observed in earlier studies, several limitations should be noted, and further studies will be crucial to further define the role of acalabrutinib in the treatment paradigm.