APPROVED IN WALDENSTRÖM’S MACROGLOBULINEMIA

THE BTK INHIBITOR THAT DELIVERS POWERFUL AND SUSTAINED RESPONSES IN WALDENSTRÖM’S MACROGLOBULINEMIA

BRUKINSA VS IBRUTINIB: THE FIRST AND ONLY
HEAD-TO-HEAD TRIAL OF BTK INHIBITORS IN WM

Powerful and consistent responses with BRUKINSA across
WM PATIENTS REGARDLESS OF LINE OF THERAPY OR MUTATION

While the primary endpoint of superiority did not reach
statistical significance, numerically higher VGPR rates were
achieved in the BRUKINSA treatment arm.1



ASPEN (STUDY 302)

All patients1

IWWM-6 criteria*

(Cohort 1)
BRUKINSA (n=102)
78
%VGPR+PR
16
%VGPR
62
%PR
Ibrutinib (n=99)
78
%VGPR+PR
7
%VGPR
71
%PR

All patients1

Modified IWWM-6 criteria*

(Cohort 1)
BRUKINSA (n=102)
78
%VGPR+PR
28
%VGPR
49
%PR
Ibrutinib (n=99)
78
%VGPR+PR
19
%VGPR
59
%PR

Median follow-up time was 19.4 months.3

The prespecified efficacy outcome measure of VGPR/CR
was assessed by IRC.1

The ASPEN Study (Study 302) assessed the efficacy of BRUKINSA in 229 adult patients with WM. ASPEN was a Phase 3, randomized, open-label, multicenter study. Histologic diagnosis of WM, meeting ≥1 criterion for treatment initiation, and no prior BTK inhibitors were required for response assessment.

*IWWM-6 criteria (Owen et al, 2013) requires complete resolution of extramedullary disease (EMD) if present at baseline for VGPR to be assessed. Modified IWWM-6 criteria (Treon, 2015) requires a reduction in EMD if present at baseline for VGPR to be assessed. 4,5

There were no CRs in either treatment arm.


BTK=Bruton’s tyrosine kinase; CI=confidence interval; CR=complete response; IRC=independent review committee; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; NCCN=National Comprehensive Cancer Network; PBMCs=peripheral blood mononuclear cells; PR=partial response; VGPR=very good partial response.

View Efficacy Results
NCCN
Category 1
Preferred
Zanubrutinib (BRUKINSA®) is included as a category 1 preferred treatment option for front-line and previously treated WM in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)6

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