BRUKINSA monotherapy is approved by HSE for CLL in adults who:3
- Are TN and have del(17p) and/or TP53-mutated disease
- Have R/R disease following at least one line of prior therapy
BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL1,4–9
Select one of the two options below:
Median follow-up 29.6 months
Primary endpoint: investigator-assessed ORR6
80%
BRUKINSA
VS
71%
ibrutinib
superiority two-sided p=0.0133
Key secondary endpoint: PFS vs ibrutinib6
HR=0.65
(95% CI: 0.49, 0.86); p=0.0024
Higher and deeper responses with superior PFS compared to ibrutinib in R/R CLL12
Investigator assessed; median follow-up: 42.5 months
PFS vs ibrutinib
HR=0.68
(95% CI: 0.54, 0.84)
Long-term follow-up: 48-month ORR
Investigator-assessed; median follow-up 42.5 months
Adapted from Brown, et al. 2024.12
PFS in patients with del(17p),
TP53 mutation or both vs ibrutinib12
Investigator assessed; median follow-up: 42.5 months
HR=0.51
(95% CI: 0.33, 0.78)
Adapted from Brown, et al. 2024.12
Overall median follow-up: 42.5 months
Atrial fibrillation
7%
BRUKINSA
(n=23/324)
VS
17%
ibrutinib
(n=55/324)
Treatment discontinuation due to cardiac AEs
1%
BRUKINSA
(n=3/324)
VS
5%
ibrutinib
(n=16/324)
Treatment discontinuation due to AEs
Overall median follow-up: 42.5 months
20%
BRUKINSA
(n=65/324)
VS
28%
ibrutinib
(n=89/324)
Median PFS with BRUKINSA in R/R CLL9
Median follow-up: 63.4 months
52.5 months
(95% CI: 49.7, 65.8)
