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ASPEN study

Indication

BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or as first-line treatment for patients unsuitable for chemo-immunotherapy.1

The pivotal ASPEN study (NCT03053440) was a global, randomised, open-label, head-to-head, Phase 3 study for the treatment of patients with WM.2,3

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  • Primary endpoint: Proportion of patients achieving a CR or a VGPR by IRC based on the response criteria updated at the 6th IWWM2
  • Secondary endpoints for Cohort 1: MRR, PFS, DOR, investigator-assessed efficacy outcomes (rate of CR or VGPR) and safety2
  • Primary endpoint: The ASPEN trial did not meet its primary endpoint. VGPRs were numerically higher with BRUKINSA2
    • There were no CRs in either treatment group in the primary analysis

Primary endpoint: CR/VGPR in patients with MYD88MUT WM*2

Adapted from Tam CS, et al. 2020.2

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Efficacy outcomes across genetic subgroups3

  • Median follow-up 44.4 months in Cohort 1; 42.9 months in Cohort 2

42-month PFS: Event-free rates
Cohort 1 Cohort 2
% MYD88MUT CXCR4MUT CXCR4WT MYD88WT
BRUKINSA 78% 73% 81% 54%
Ibrutinib 70% 49% 75% -
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Patients with a best response of CR/VGPR
Cohort 1 Cohort 2
n, (%) MYD88MUT CXCR4MUT CXCR4WT MYD88WT
BRUKINSA 37 (36) 7 (21) 29 (45) 8 (31)
Ibrutinib 25 (25) 2 (10) 22 (31) -

Adapted from Dimopoulos, et al. 2023.3

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Investigator-assessed response rates increased over time4

In patients treated with BRUKINSA at 84 months of follow up:

  • The ORR was 96.1% and the VGPR+ rate was 40.2%, including 2.0% CR, in Cohort 1 (MYD88MUT)
    • The median duration of response was not yet reached
  • The ORR was 84.6% and the VGPR+ rate was 30.8%, including 3.8% CR, in Cohort 2 (MYD88WT)
    • The median duration of response was 41.1 months (95% CI: 15.7%, NE)

Best overall response rates in patients with WM receiving BRUKINSA at extended follow-up4

Cohort 1: patients with MYD88 mutation, n=102;
Cohort 2: patients with MYD88 wild type, n=28; median follow-up 69.8 months

Adapted from D'Sa, et al. 2024.4

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Prevalence of AEs of special interest at >36 months3

BRUKINSA (n=72); ibrutinib (n=64)‡

Adapted from Dimopoulos, et al. 2023.3

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  • In Cohort 1, BRUKINSA was generally well tolerated, with fewer treatment discontinuations and dose reductions vs ibrutinib:3
    • AE leading to dose reduction: 16% (16/101) vs 27% (26/98)
    • AE leading to treatment discontinuation: 9% (9/101) vs 20% (20/98)
  • In Cohort 2, 7% (2/28) patients had a dose reduction and 21% (6/28) discontinued BRUKINSA3

With extended treatment and follow-up in the long-term extension study (n=72):¶4

There were no discontinuations due to TEAEs

Grade ≥3 and serious AESIs for BTK inhibitors were rare

Median treatment duration with BRUKINSA was 73.5 months (range: 22.3–84.2).4

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