HSE recommends BRUKINSA as monotherapy for the treatment of adult patients with CLL:1
- Who are treatment naive and have del(17p) and/or TP53-mutated disease
- Who 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 CLL2–6
Select one of the two options below:
Median follow-up 29.6 months
Primary endpoint: investigator-assessed ORR4
79.5%
BRUKINSA
VS
71.1%
ibrutinib
superiority two-sided p=0.0133
Key secondary endpoint: PFS vs ibrutinib4
HR=0.65
(95% CI: 0.49, 0.86); p=0.0024
Benefit was maintained with extended follow-up12
Overall median follow-up: 42.5 months
PFS vs ibrutinib
HR=0.68
(95% CI: 0.54, 0.84)
Investigator-assessed ORR at 42.5 months
Adapted from Brown, et al. 2024.12
PFS in patients with del(17p),
TP53 mutation or both vs ibrutinib
Overall 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
7.1%
BRUKINSA
(n=23/324)
VS
17.0%
ibrutinib
(n=55/324)
Treatment discontinuation due to cardiac AEs
0.9%
BRUKINSA
(n=3/324)
VS
4.9%
ibrutinib
(n=16/324)
Treatment discontinuation due to AEs
Overall median follow-up: 42.5 months
20.1%
BRUKINSA
(n=65/324)
VS
27.5%
ibrutinib
(n=89/324)
