IMBRUVICA®’s evidence is backed by multiple phase II/III clinical trials and real-world studies[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]
![Phase Ib/II PCYC-1102/1103 85.0 months median follow up[^1][^1]: Byrd JC, <em>et al.</em> Ibrutinib treatment for first-line and relapsed/refractory chronic lymphocytic leukemia: Final analysis of the pivotal phase Ib/II PCYC-1102 study. <em>Clin Cancer Res.</em> 2020;26(15):3918–3927.](https://eu-images.contentstack.com/v3/assets/blt6b8ca7f1bf9e5733/blt508364b1c6621415/636ba928462dd610fd2ac6ee/3_year_pfs-background.png?width=1920&height=378&format=webp&quality=50)
Phase Ib/II PCYC-1102/1103 85.0 months median follow up[1]
PCYC-1102/1103
The PCYC-1102/1103 study was a phase Ib/II, open-label, non-randomised study of IMBRUVICA® in firstline and R/R CLL patients.[1]
Firstline studies
RESONATE-2
The RESONATE-2 study was an open-label, multicentre, randomised phase III study to establish the long-term safety and efficacy of IMBRUVICA® vs. chlorambucil in firstline CLL patients.[2][3]
ECOG 1912
The ECOG 1912 study was an open-label, randomised, phase III study comparing treatment with IMBRUVICA® + rituximab vs. fludarabine + cyclophosphamide + rituximab in firstline CLL patients.[4][5]
ALLIANCE
The ALLIANCE study was a randomised, phase III study comparing the treatment regimens bendamustine + rituximab, IMBRUVICA® + rituximab and IMBRUVICA® alone in firstline CLL patients.[6]
iLLUMINATE
The iLLUMINATE study was an open-label, multicentre, randomised, phase III study comparing the treatment regimens IMBRUVICA® + obinutuzumab vs. chlorambucil + obinutuzumab in firstline CLL patients.[7][16]
Relapsed/refractory studies
RESONATE
The RESONATE study was a randomised, multicentre, open-label, phase III study that evaluated the efficacy and safety of IMBRUVICA® vs. ofatumumab in patients with R/R CLL/SLL.[8]
HELIOS
The HELIOS study was a randomised, double-blind, placebo-controlled phase III study comparing IMBRUVICA® + bendamustine + rituximab vs. placebo + bendamustine + rituximab in patients with R/R CLL/SLL.[9][10]
Real-world studies
BiRD
The BiRD study was a multicentre, observational study assessing the effectiveness and safety of IMBRUVICA® in patients aged ≥18 years with CLL.[11]
FIRE
The FIRE study was a multicentre, retrospective and prospective non-interventional study assessing IMBRUVICA® outcomes in patients aged ≥18 years with CLL.[12]
IBRORS
The IBRORS CLL study was an observational, retrospective, multicentre, national study focused on collecting information to describe the effects of IMBRUVICA® in patients with CLL.[13][15]
CLL=chronic lymphocytic leukaemia; MCL=mantel cell lymphoma; R/R=relapsed/refractory; SLL=small lymphocytic lymphoma.
