Skip to content

This site is intended for UK healthcare professionals only. If you are not a UK healthcare professional, please visit our dedicated site for more information at beonemedicines.co.uk

BRUKINSA logo

SEQUOIA study

Indication

BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).1

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.3

Scroll left and right to see more
  • 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 patients4,5

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)1,3

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

  • Cohort 2 was a separate single-arm exploratory cohort for patients known to respond poorly to CIT3
  • This cohort is one of the largest prospective datasets in this population3

Over 75% of TN CLL patients without del(17p) were free of disease progression at 5 years4

PFS in patients without del(17p)4

Scroll left and right to see more

Adapted from Shadman M, et al. 2025.4

Patients with del(17p) achieved PFS comparable to those without high-risk features4,5

  • SEQUOIA 5-year PFS: 72% with del(17p)5

BRUKINSA demonstrated sustained PFS regardless of IGHV status4,5

  • Similar PFS was observed in patients with mutated and unmutated IGHV treated with BRUKINSA4,5
PFS in patients by IGHV mutational status4,5 PFS events (% of patients) HR (95% CI)
Patients without
del(17p)		 BRUKINSA Mutated IGHV (n=109) 17.4 1.35 (0.76, 2.40)
Unmutated IGHV (n=125) 23.2
BR Mutated IGHV (n=109) 35.8 NS
Unmutated IGHV (n=123) 61.0
Patients with
del(17p)		 BRUKINSA Mutated IGHV (n=36) 74.6 NS
Unmutated IGHV (n=67) 70.7
Scroll left and right to see more

Data cut-off: 30 April 2024.4,5

A well-tolerated treatment for patients with CLL, associated with low rates of discontinuation and dose reduction4,5

Cohort 1 – patients without del(17p): 20% AE-related treatment discontinuations at mFU 61.2 months4

  • 68% of patients remained on BRUKINSA treatment (n=163/240)

Cohort 2 – patients with del(17p): 17% AE-related treatment discontinuations at mFU 65.8 months5

EAIRs for select AEs of special interest‡4

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. 2025.4

Patients treated with BRUKINSA reported better health-related QoL outcomes and fewer GI symptoms vs CIT6

  • Patient-reported outcomes were better with BRUKINSA vs BR at Week 246
  • Fewer GI symptoms were reported with BRUKINSA vs BR at Week 246
Learn more about BRUKINSA:
Select an indication to learn more about BRUKINSA: