Key clinical trials with ibrutinib in CLL
Name | Phase | Population | Response | Ref |
---|---|---|---|---|
N/A | IB/II | R/R | 71% ORR | [62] |
Resonate | III | R/R | Demonstrated that ibrutinib was superior to ofatumumab for response rate, PFS | [63] |
N/A | I/IB | TN | 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