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ALPINE study

Indication

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

The pivotal ALPINE study (NCT03734016) is a global, randomised, open-label, head-to-head, Phase 3 study for the treatment of patients with R/R CLL/SLL.2

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  • Primary endpoint: Investigator-assessed ORR (PR + CR)
  • Key secondary endpoints: Investigator-assessed PFS, incidence of atrial fibrillation or flutter
  • Other secondary endpoints: PR-L or better, DOR, time to treatment failure, OS, safety

BRUKINSA is the first and only BTK inhibitor to achieve superior ORR and PFS vs ibrutinib in R/R CLL:2–4

  • Primary endpoint: At 24 months, BRUKINSA achieved a superior ORR vs ibrutinib (79.5% [95% CI: 74.7, 83.8] vs 71.1% [95% CI: 65.8, 75.9]; superiority two-sided p=0.0133)2
  • 48-month ORR: 90% BRUKINSA vs 83% ibrutinib4

Long-term follow-up: PFS (ITT population)4

Adapted from Brown JR, et al. 2024.4

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PFS rates were favourable across major subgroups:4

  • In patients with del(17p)/TP53 mutations (HR=0.51 [95% CI: 0.33, 0.78])4

BRUKINSA had a favourable safety profile vs ibrutinib, including lower rates of atrial fibrillation/flutter at 3.5-year follow-up4

Overall safety and tolerability4
Event n (%) BRUKINSA (n=324) Ibrutinib (n=324)
≥1 AE 322 (99.4) 323 (99.7)
Grade ≥3 AEs 242 (74.7) 256 (79.0)
All serious AEs 172 (53.1) 196 (60.5)
Dose reduction 49 (15.1) 61 (18.8)
Treatment discontinuation 65 (20.1) 89 (27.5)

Median duration of treatment exposure: 41.2 months BRUKINSA vs 37.8 months ibrutinib.4

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Adverse events of special interest4
Event n (%) BRUKINSA (n=324) Ibrutinib (n=324)
Infection 266 (82.1) 262 (80.9)
Bleeding 145 (44.8) 146 (45.1)
Neutropenia 102 (31.5) 96 (29.6)
Hypertension 88 (27.2) 82 (25.3)
Anaemia 54 (16.7) 60 (18.5)
Second primary malignancies 46 (14.2) 53 (16.4)
Thrombocytopenia 44 (13.6) 53 (16.4)
Atrial fibrillation/flutter 23 (7.1) 55 (17.0)
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  • There were 6 fatal cardiac events in patients treated with ibrutinib and none with BRUKINSA4
Event n (%) BRUKINSA (n=324) Ibrutinib (n=324)
Cardiac AEs 84 (25.9) 115 (35.5)
Serious cardiac AEs 13 (4.0) 32 (9.9)
Cardiac AEs leading to treatment discontinuation 3 (0.9) 16 (4.9)

Incidence of atrial fibrillation/flutter4

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Adapted from Brown JR, et al. 2024.4

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