Key clinical trials with ibrutinib in CLL

Name Phase Population Response Ref
N/A IB/II R/Rb 71% ORRc by standard response criteria. Additional 18% partial response with persistent lymphocytosis [62]
Resonate III R/R Demonstrated that ibrutinib was superior to ofatumumab for response rate, PFSd and OSe [63]
N/A I/IB TNf ≥ 65 years 90% achieved objective response or partial response with persistent lymphocytosis [64]
Resonate-2 III TN ≥ 65 years Demonstrated that ibrutinib was superior to chlorambucil for overall response rate, PFS and OS [65]
Helios III R/R Ibrutinib + bendamustine/rituximab superior to bendamustine/rituximab for PFS and OS [66, 67]
Alliance A041202 III TN ≥ 65 years Ibrutinib superior to bendamustine + rituximab for PFS. No difference between ibrutinib or ibrutinib + rituximab for PFS [68]
ECOG 1912 III TN ≤ 70 years Ibrutinib + rituximab superior to CIT for PFS and OS at interim analysis [69]
iLLUMINATE III TN ≥ 65 years or < 65 years with coexisting conditions Ibrutinib + obinutuzumab superior to chlorambucil + obinutuzumab for PFS [70]

N/A: not applicable;

R/R: relapsed/refractory;

ORR: overall response rate;

PFS: progression-free survival;

OS: overall survival;

TN: treatment naïve