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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.3,4

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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 only BTK inhibitor with proven superior efficacy over ibrutinib in R/R CLL:3,5,6

  • Primary endpoint: At 24 months, BRUKINSA achieved a superior ORR vs ibrutinib (80% [95% CI: 74.7, 83.8] vs 71% [95% CI: 65.8, 75.9]; superiority two-sided p=0.0133)3
  • 48-month ORR (PR-L or better): 90% BRUKINSA vs 83% ibrutinib5

Extended follow-up: PFS5

Adapted from Brown JR, et al. 2024.5

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BRUKINSA showed an even greater PFS advantage in patients with del(17p)/TP53 mutations3,5

  • PFS in R/R CLL with del(17p) and/or TP53 mutation vs ibrutinib: HR=0.51 (95% CI: 0.33, 0.78); median follow-up: 42.5 months5

Median PFS with BRUKINSA was 52.5 months (95% CI: 49.7, 65.8) with 63.4 months median follow-up7

Favourable safety profile vs ibrutinib, including lower rates of atrial fibrillation/flutter (median follow-up: 42.5 months)5

Overall safety and tolerability5
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.5

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Adverse events of special interest5
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)

Adapted from Brown JR, et al. 2024.5

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The incidence of key AESIs remained stable or reduced over time with BRUKINSA7

Median duration of treatment exposure: 52.5 months BRUKINSA7

Prevalence of recurrent AESIs over time7

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Adapted from Tam CS, et al. 2025.7

  • There were 6 fatal cardiac events in patients treated with ibrutinib and none with BRUKINSA5
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/flutter5

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Adapted from Brown JR, et al. 2024.5

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