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:
- Primary endpoint: IRC-assessed PFS (N=479)4
- At a median follow-up of 25.0 months, BRUKINSA demonstrated superior PFS vs BR; HR=0.42 (95% CI: 0.28, 0.63); p<0.00011,4
Nearly three-quarters of patients without del(17p) remained progression free at 6 years10
Extended follow-up: PFS in patients without del(17p)10
Investigator-assessed; median follow-up: 72.8 months10
HR=0.28
(95% CI: 0.20, 0.38); p<0.0001
Adapted from Tam CS, et al. 2025.10
BRUKINSA demonstrated sustained PFS benefit regardless of IGHV mutation status10
Long-term follow-up: Number of PFS events by IGHV mutational status in patients without del(17p)10
Median follow-up: 72.8 months
Unmutated IGHV:
36 (29%)
n=248
Mutated IGHV:
21 (19%)
n=218
No significant difference between mutated and unmutated IGHV subgroups treated with BRUKINSA: HR=1.49; p=0.1410
Patients with del(17p) achieved progression-free survival comparable to those without high-risk features10
Long-term follow-up: PFS in patients with del(17p)10
Investigator-assessed; median follow-up: 76.7 months10
Estimated 72-month PFS in patients with del(17p) was 65% with mutated IGHV and 64% with unmutated IGHV10
Adapted from Tam CS, et al. 2025.10
Patients without del(17p)
Adapted from Tam CS, et al. 2025.10
Patients with del(17p)
Adapted from Tam CS, et al. 2025.10
Responses with BRUKINSA deepened over time10,13
Patient-reported outcomes were better with
BRUKINSA vs BR at Week 24
(N=479)
GHS/QoL: p=0.0169
Physical functioning: p=0.0121
Fewer GI symptoms were reported with
BRUKINSA vs BR at Week 24
(N=479)
Diarrhoea: p=0.0012
Nausea/vomiting: p=0.0015
Most patients were still taking BRUKINSA at ~6 years median follow-up10
Patients without del(17p):
59%
Median follow-up: 72.8 months; n=142/241
Patients with del(17p):
55%
Median follow-up: 76.7 months; n=61/110
