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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

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  • 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 patients3,4

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
  • Median PFS was not reached with BRUKINSA vs 44.1 months with BR at 61.2 months median follow-up4

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

Nearly three-quarters of patients (74%) without del(17p) remained progression free at 72 months5

PFS in patients without del(17p)5

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Adapted from Tam CS, et al. 2025.5

Patients with del(17p) achieved PFS comparable to those without high-risk features5

  • SEQUOIA 6-year PFS: 64% with del(17p)5

BRUKINSA demonstrated sustained PFS regardless of IGHV status5

  • Similar PFS was observed in patients with mutated and unmutated IGHV treated with BRUKINSA5
PFS in patients by IGHV mutational status5 PFS events (% of patients) HR
Patients without
del(17p)
BRUKINSA Mutated IGHV (n=109) 19 1.49; p=0.14
Unmutated IGHV (n=125) 29
BR Mutated IGHV (n=109) 46 NS
Unmutated IGHV (n=123) 64
Patients with
del(17p)
BRUKINSA Mutated IGHV (n=36) 33 NS
Unmutated IGHV (n=67) 37
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Data cut-off: 30 April 2025.5

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

At ~6 years median follow-up:

  • 59% of patients without del(17p) remained on BRUKINSA (n=142/240)
  • 55% of patients with del(17p) remained on BRUKINSA (n=61/111)

TEAEs and post-treatment AEs of special interest (any grade in ≥15% of patients) at 6-year median follow-up‡5

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Adapted from Tam CS, et al. 2025.5

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