All-oral, once-daily, fixed-duration IMBRUVICA® + venetoclax demonstrated deep, durable responses and sustained PFS[1]
The combination of IMBRUVICA® + venetoclax is being investigated across several studies. Data from the GLOW Phase III clinical trial and the CAPTIVATE Phase II trial supported the approval of this combination by EMA for the treatment of CLL/SLL.[1][2]
More information on the study populations and trial designs can be viewed below:
A Phase III study evaluating the efficacy and safety of first-line IMBRUVICA® + venetoclax combination therapy in patients with CLL who are older and/or have comorbidities[1]
An international multicentre Phase II study evaluating the IMBRUVICA® + venetoclax combination therapy in previously untreated CLL patients aged ≤70 years[2]
Uncover the key efficacy data of IMBRUVICA® + venetoclax combination therapy in CLL
GLOW: IMBRUVICA® + venetoclax provides significantly higher progression-free survival vs Clb+O in elderly and unfit patients[1]
IMBRUVICA® + venetoclax reduced the risk of disease progression by 78%[1]*
Primary endpoint: Progression-free survival
Adapted from Kater AP, et al. 2022.[1]
GLOW: Over 50% of patients on IMBRUVICA® + venetoclax achieved uMRD in peripheral blood and bone marrow[1]
IMBRUVICA® + venetoclax achieved significantly higher uMRD rates vs Clb+O in:
uMRD at 3 months after end of treatment
Adapted from Kater P, et al. 2022.[1]
GLOW: Lymph node responses were largely maintained over time in the IMBRUVICA + venetoclax arm
Adapted from Kater AP, et al. Supplementary Appendix. 2022[1]
IMBRUVICA effectively mobilises CLL cells out of lymph nodes to be targeted by BCL-2 inhibition[3]
- Overall, 84.5% of patients on IMBRUVICA® + venetoclax had sustained uMRD from 3 to 12 months after end of treatment[1]†
- IMBRUVICA® + venetoclax delivered >90% sustained PFS in the first year post-treatment regardless of MRD status[1]‡
GLOW: IMBRUVICA® + venetoclax prolonged time to next treatment[1]*
IMBRUVICA® + venetoclax reduced the risk of needing second-line therapy by 86% (HR: 0.143 95% CI: 0.05–0.41]vs standard-of-care chemoimmunotherapy[1]*
Time to next treatment
Adapted from Kater AP, et al. 2022.[1]
CAPTIVATE: Fixed duration IMBRUVICA® + venetoclax delivered deep, durable responses in patients with CLL <70 years old[2]
IMBRUVICA® + venetoclax achieved high rates of CR and PFS in high-risk patients[2][4]§
Best overall response[2]
Adapted from Moreno C, et al. 2022.[2]
- Primary endpoint (proportion with complete response [CR], with or without bone marrow recovery) in patients without del(17p) mutation was achieved by >55% of the all-treated population[4]
- IMBRUVICA® + venetoclax delivered 95% PFS after more than two years follow-up for all-treated patients[4]††
- The rates of MRD undetectability were also high: 77% in the peripheral blood and 60% in the bone marrow[4]
CAPTIVATE: IMBRUVICA® + venetoclax delivered high PFS rates in patients with CLL, including those with high-risk features[2][4]
Progression-free survival
IMBRUVICA® + venetoclax achieved sustained PFS in all treated patients[2]
Adapted from Moreno C, et al. 2022.[2]
IMBRUVICA® + venetoclax achieved sustained PFS in high-risk patients
Adapted from Moreno C, et al. 2022.[2]
Discussion on the efficacy of IMBRUVICA® + venetoclax in CLL
What do leading experts think the efficacy data for IMBRUVICA® + venetoclax combination therapy means to clinical practice?
Discover the synergistic MoA of IMBRUVICA® + venetoclax
Explore the safety of IMBRUVICA® + venetoclax in CLL
BCL-2=B-cell lymphoma 2; CI=confidence interval; Clb+O=chlorambucil + obinutuzumab; CLL=chronic lymphocytic leukaemia; CR=complete response; CRi=complete response with incomplete bone marrow recovery; EMA=European Medicines Agency; HR=hazard ratio; (u)MRD=(undetectable) minimal residual disease; nPR=nodular partial response; PFS=progression-free survival; SLL=small lymphocytic lymphoma; SPD=sum of the product of perpendicular dimensions; uIGHV=unmutated immunoglobulin heavy chain variable.
*vs Clb+O at a median follow-up 27.7 months.[1]
†vs Clb+O.[1]
‡At a median follow-up of 34.1 months, irrespective of MRD status in bone marrow at 3 months after end of treatment.[1]
§56% CR/CRi in patients with del(17p) (n=27). 57% CR/CRi in all treated patients (N=159). 64% CR/CRi in patients with unmutated IGHV. 86% estimated PFS in patients with uIGHV CLL (n=89/159) at 3 years. 80% estimated PFS in patients with del(17p)/TP53 mutations (n=27/159) at 3 years. 88% estimated PFS in all treated patients (N=159) at 3 years.[2]
¶CR rate is inclusive of patients achieving CRi.[2]
**PR rate is inclusive of patients achieving nPR.[2]
††At median follow-up of 27.9 months by investigator assessment (95% CI, 90-97).[4]
‡‡89 out of 159 patients had uIGHV CLL.[2]
§§27 out of 159 patients had del(17p)/TP53.[2]
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