Key clinical trials with ibrutinib in CLL

NamePhasePopulationResponseRef
N/AIB/IIR/Rb71% ORRc by standard response criteria. Additional 18% partial response with persistent lymphocytosis[62]
ResonateIIIR/RDemonstrated that ibrutinib was superior to ofatumumab for response rate, PFSd and OSe[63]
N/AI/IBTNf ≥ 65 years90% achieved objective response or partial response with persistent lymphocytosis[64]
Resonate-2IIITN ≥ 65 yearsDemonstrated that ibrutinib was superior to chlorambucil for overall response rate, PFS and OS[65]
HeliosIIIR/RIbrutinib + bendamustine/rituximab superior to bendamustine/rituximab for PFS and OS[66, 67]
Alliance A041202IIITN ≥ 65 yearsIbrutinib superior to bendamustine + rituximab for PFS. No difference between ibrutinib or ibrutinib + rituximab for PFS[68]
ECOG 1912IIITN ≤ 70 yearsIbrutinib + rituximab superior to CIT for PFS and OS at interim analysis[69]
iLLUMINATEIIITN ≥ 65 years or < 65 years with coexisting conditionsIbrutinib + 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