Waldenström's macroglobulinaemia (WM) - Brukinsa®▼ (zanubrutinib)

NICE recommends BRUKINSA as an option for treating adult patients with WM who have had at least one treatment, only if BR is also suitable.³

It is only recommended if the company provides it according to the commercial arrangement.³

BRUKINSA monotherapy is accepted by SMC as an option for treating WM in adults who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.⁴

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.⁴

ASPEN was the first and only head-to-head BTKi trial in WM, with up to 6 years follow-up^5–10

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation⁵

28%

BRUKINSA

(n=29/102)

19%

ibrutinib

(n=19/99)

There were no CRs in either treatment arm⁵

While the primary endpoint of superiority did not reach
statistical significance (p=0.09), numerically higher VGPR rates
were achieved in the BRUKINSA treatment arm at a median
follow-up of 19.4 months⁵

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁶

Median follow-up 44.4 months; patients with MYD88 mutation

VGPR

36%

BRUKINSA

(n=37/102)

25%

ibrutinib

(n=25/99)

MRR

81%

BRUKINSA

80%

ibrutinib

Median follow-up: 44.4 months; patients with MYD88 mutation

VGPR/CR in TN patients

37%

BRUKINSA

(n=7/19)

22%

ibrutinib

(n=4/18)

VGPR/CR in patients with 1–3 lines prior therapy

37%

BRUKINSA

(n=28/76)

26%

ibrutinib

(n=19/74)

Secondary endpoint: Responses in patients with
MYD88 wild type⁶

Investigator-assessed; median follow-up: 42.9 months

Adapted from Dimopoulos, et al. 2023.⁶

Best overall response rates in patients with WM receiving BRUKINSA¹⁰

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. 2024.¹⁰

Significantly fewer GI symptoms were reported at the start of treatment with BRUKINSA than with ibrutinib

Cycle 4; (N=201)

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

Among patients achieving a VGPR, patient-reported
outcomes at 6 months showed a greater improvement with BRUKINSA than with ibrutinib

Cycle 25; (n=48)

Fatigue: p=0.0220

Physical functioning: p=0.0476

Any-grade; patients with >36 months follow-up

BRUKINSA

(n=72)

17%

ibrutinib

(n=64)

Treatment discontinuations due to AEs

BRUKINSA

(n=9/101)

20%

ibrutinib

(n=20/98)

Dose reductions due to AEs

16%

BRUKINSA

(n=16/101)

27%

ibrutinib

(n=26/98)

ASPEN was the first and only head-to-head BTKi trial in WM, with up to 6 years follow-up^5–10

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation⁵

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁶

VGPR

MRR

VGPR/CR in TN patients

VGPR/CR in patients with 1–3 lines prior therapy

Secondary endpoint: Responses in patients with
MYD88 wild type⁶

Best overall response rates in patients with WM receiving BRUKINSA¹⁰

Significantly fewer GI symptoms were reported at the start of treatment with BRUKINSA than with ibrutinib

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

Among patients achieving a VGPR, patient-reported
outcomes at 6 months showed a greater improvement with BRUKINSA than with ibrutinib

Fatigue: p=0.0220

Physical functioning: p=0.0476

Any-grade; patients with >36 months follow-up

Treatment discontinuations due to AEs

Dose reductions due to AEs

READ ABOUT THE ASPEN STUDY

Learn more about BRUKINSA:

Select an indication to learn more about BRUKINSA:

ASPEN was the first and only head-to-head BTKi trial in WM, with up to 6 years follow-up5–10

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA vs ibrutinib in patients with MYD88 mutation5

Numerically higher VGPR and MRR rates vs ibrutinib at extended follow-up6

VGPR

MRR

VGPR/CR in TN patients

VGPR/CR in patients with 1–3 lines prior therapy

Secondary endpoint: Responses in patients with MYD88 wild type6

Best overall response rates in patients with WM receiving BRUKINSA10

Significantly fewer GI symptoms were reported at the start of treatment with BRUKINSA than with ibrutinib

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

Among patients achieving a VGPR, patient-reported outcomes at 6 months showed a greater improvement with BRUKINSA than with ibrutinib

Fatigue: p=0.0220

Physical functioning: p=0.0476

Any-grade; patients with >36 months follow-up

Treatment discontinuations due to AEs

Dose reductions due to AEs

READ ABOUT THE ASPEN STUDY

Learn more about BRUKINSA:

Select an indication to learn more about BRUKINSA:

ASPEN was the first and only head-to-head BTKi trial in WM, with up to 6 years follow-up^5–10

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation⁵

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁶

Secondary endpoint: Responses in patients with
MYD88 wild type⁶

Best overall response rates in patients with WM receiving BRUKINSA¹⁰

Among patients achieving a VGPR, patient-reported
outcomes at 6 months showed a greater improvement with BRUKINSA than with ibrutinib