Safety of IMBRUVICA® + venetoclax in chronic lymphocytic leukaemia (CLL)
CAPTIVATE: A 3-cycle lead-in with IMBRUVICA® effectively debulks the tumor[1]
Following 3 cycles of IMBRUVICA® lead-in:
Component not published? componentType is undefined.
Combination of IMBRUVICA® + venetoclax demonstrated no new safety signals[1][2][3][4][5][6]*
GLOW: Occurrence of side-effects
The safety profile of IMBRUVICA® + venetoclax was consistent with known side-effects for each individual drug
GLOW: Grade 3 or higher AEs in ≥5% of patients at a median follow-up of 27.7 months[2]
Adapted from Kater AP, et al. 2022.[2]
*No new safety signals when comparing adverse events on IMBRUVICA® + venetoclax combination therapy versus either as monotherapy in CLL.[1][2][3][4][5][6]
- 77.4% of patients completed treatment with few side-effects restricting treatment with IMBRUVICA®+ venetoclax[2]
- Four patients treated with IMBRUVICA® + venetoclax required subsequent therapy compared with 27 patients receiving standard-of-care (hazard ratio, 0.143; 95% CI, 0.050–0.410)[2]
CAPTIVATE: Occurrence of side-effects
92% of patients completed the full fixed-duration IMBRUVICA® + venetoclax treatment regimen[3]
Most frequent grade 1/2 AEs (>30%) at 38.7 months median follow-up[3]
62% for any grade
42% for any grade
41% for any grade
33% for any grade
- IMBRUVICA® + venetoclax achieved high completion rates and a reduction in tumour lysis syndrome risk[1]*§
What are the clinical practicalities associated with I + V?
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[2]
An international multicentre Phase II study evaluating the IMBRUVICA® + venetoclax combination therapy in previously untreated CLL patients aged ≤70 years[3]
The GLOW and the CAPTIVATE trials have both demonstrated that IMBRUVICA® + venetoclax can elicit durable responses and favourable safety profiles in patients with CLL
demonstrated IMBRUVICA® + venetoclax efficacy in older patients with comorbidities[2]
supported the efficacy of IMBRUVICA® + venetoclax in fit patients ≤70 years old with CLL[3]
Taken together, findings from both trials support combination treatment with IMBRUVICA® + venetoclax across a broad range of patients with previously untreated CLL[2][3]
Explore the efficacy of IMBRUVICA® + venetoclax
Discover the dosing regimen of IMBRUVICA® + venetoclax
AE=adverse event; CI=confidence interval; Clb+O=chlorambucil + obinutuzumab; CLL=chronic lymphocytic leukaemia; mos=months; TLS=tumour lysis syndrome.
*No new safety signals when comparing adverse events on IMBRUVICA® + venetoclax combination therapy versus either as monotherapy in CLL.[1][2][3][4][5][6]
†Includes ‘neutrophil count decreased’; grade ≥3 febrile neutropenia: 1.9% for IMBRUVICA® + venetoclax vs 2.9% for Clb+O.[2]
ǂIncludes multiple preferred terms.[2]
§In the CAPTIVATE study, 94% (32/34) of patients moved from a high- to medium- or low-risk TLS category.[1]
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