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.¹

It is only recommended if the company provides it according to the commercial arrangement.¹

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.²

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.²

ASPEN is the first and only head-to-head BTK inhibitor study in WM, with ~4 years median follow-up^3–5

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation³

28%

BRUKINSA

(n=29/102)

19%

ibrutinib

(n=19/99)

There were no CRs in either treatment arm³

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 months³

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁵

Median follow-up 44.4 months; patients with MYD88 mutation

VGPR

36.3%

BRUKINSA

(n=37/102)

25.3%

ibrutinib

(n=25/99)

MRR

81.4%

BRUKINSA

79.8%

ibrutinib

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

VGPR/CR in TN patients

36.8%

BRUKINSA

(n=7/19)

22.2%

ibrutinib

(n=4/18)

Patients with 1–3 lines prior therapy

36.8%

BRUKINSA

(n=28/76)

25.7%

ibrutinib

(n=19/74)

Secondary endpoint: Responses in patients with
MYD88 wild type⁵

Investigator-assessed; median follow-up: 42.9 months

Adapted from Dimopoulos, et al. 2023.⁵

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. 2024.⁶

Less patient-reported diarrhoea, nausea and vomiting
at the start of BRUKINSA treatment vs ibrutinib

Cycle 4; (N=201)

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

At 6 months, patients who had achieved a VGPR
reported less fatigue with BRUKINSA vs 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

8.9%

BRUKINSA

(n=9/101)

20.4%

ibrutinib

(n=20/98)

Dose reductions

15.8%

BRUKINSA

(n=16/101)

26.5%

ibrutinib

(n=26/98)

ASPEN is the first and only head-to-head BTK inhibitor study in WM, with ~4 years median follow-up^3–5

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation³

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁵

VGPR

MRR

VGPR/CR in TN patients

Patients with 1–3 lines prior therapy

Secondary endpoint: Responses in patients with
MYD88 wild type⁵

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

Less patient-reported diarrhoea, nausea and vomiting
at the start of BRUKINSA treatment vs ibrutinib

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

At 6 months, patients who had achieved a VGPR
reported less fatigue with BRUKINSA vs ibrutinib

Fatigue: p=0.0220

Physical functioning: p=0.0476

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

Treatment discontinuations

Dose reductions

READ ABOUT THE ASPEN STUDY

Learn more about BRUKINSA:

Select an indication to learn more about BRUKINSA:

ASPEN is the first and only head-to-head BTK inhibitor study in WM, with ~4 years median follow-up3–5

Waldenström’s macroglobulinaemia

Primary endpoint: CR+VGPR rate with BRUKINSA vs ibrutinib in patients with MYD88 mutation3

Numerically higher VGPR and MRR rates vs ibrutinib at extended follow-up5

VGPR

MRR

VGPR/CR in TN patients

Patients with 1–3 lines prior therapy

Secondary endpoint: Responses in patients with MYD88 wild type5

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

Less patient-reported diarrhoea, nausea and vomiting at the start of BRUKINSA treatment vs ibrutinib

Diarrhoea: p=0.01

Nausea/vomiting: p=0.01

At 6 months, patients who had achieved a VGPR reported less fatigue with BRUKINSA vs ibrutinib

Fatigue: p=0.0220

Physical functioning: p=0.0476

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

Treatment discontinuations

Dose reductions

READ ABOUT THE ASPEN STUDY

Learn more about BRUKINSA:

Select an indication to learn more about BRUKINSA:

ASPEN is the first and only head-to-head BTK inhibitor study in WM, with ~4 years median follow-up^3–5

Primary endpoint: CR+VGPR rate with BRUKINSA
vs ibrutinib in patients with MYD88 mutation³

Numerically higher VGPR and MRR rates vs ibrutinib
at extended follow-up⁵

Secondary endpoint: Responses in patients with
MYD88 wild type⁵

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

Less patient-reported diarrhoea, nausea and vomiting
at the start of BRUKINSA treatment vs ibrutinib

At 6 months, patients who had achieved a VGPR
reported less fatigue with BRUKINSA vs ibrutinib