The pivotal SEQUOIA study (NCT03336333) is a multi-centre, randomised, open-label, Phase 3 study comparing BRUKINSA with bendamustine-rituximab (BR) in patients with treatment-naïve CLL or SLL.²

• Primary endpoint (Cohort 1): PFS per IRC
• Secondary endpoints included: PFS for Cohort 2, ORR, OS, DOR, safety, PFS by investigator

BRUKINSA demonstrated superior efficacy vs BR in TN CLL patients²

Cohort 1 – patients without del(17p) (n=479):

• PFS (primary endpoint): 58% relative risk reduction with BRUKINSA vs BR; IRC-assessed; HR=0.42 (95% CI: 0.28, 0.63); two-sided p<0.0001 (median follow-up for PFS: 25.0 months)^1,2

Cohort 2 – patients with del(17p) (n=111):

• Cohort 2 was a separate single-arm exploratory cohort for patients known to respond poorly to CIT²
• This cohort is one of the largest prospective datasets in this population²

The PFS benefit was maintained with long-term follow-up³

Patients with del(17p) maintained a high PFS rate of 79% with BRUKINSA at 42 months⁴

BRUKINSA demonstrated a consistent benefit regardless of IGHV mutational status³

• Similar PFS was observed in patients treated with BRUKINSA who had either mutated or unmutated IGHV genes³

Data cut-off: 30 April 2024.³

Low rates of treatment discontinuation with up to 5 years of follow-up³

Cohort 1 – patients without del(17p); 61.2 months median follow-up.³

• 68% of patients remained on BRUKINSA treatment (n=163/240)
• The rate of discontinuation due to AEs was 20.0%

Cohort 2 – patients with del(17p); 43.7 months median follow-up.⁴

• The rate of discontinuation due to AEs was 13.5%

EAIRs for select AEs of special interest^§3

AEs of special interest	BRUKINSA (n=240), EAIR (person per 100 person-months)	BR (n=227), EAIR (person per 100 person-months)
Atrial fibrillation and flutter	0.13	0.09
Haemorrhage	1.66	0.35
Major haemorrhage	0.18	0.05
Hypertension	0.50	0.38
Secondary primary malignancy	0.50	0.41
Skin cancer	0.26	0.23

Adapted from Shadman, et al. 2025.³

Patients treated with BRUKINSA reported better health-related QoL outcomes and fewer GI symptoms vs BR⁵

• Patients reported better physical functioning and reduced fatigue by week 24 with BRUKINSA vs BR⁵
• Less patient-reported diarrhoea, nausea and vomiting with BRUKINSA vs BR⁵