POWERFUL AND
SUSTAINED RESPONSES


Adults with WM rapidly achieved high response rates regardless
of line of therapy or mutation.

Powerful and consistent responses
with BRUKINSA across all WM patients

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

In all patients, median time to response (CR+VGPR+PR) was 2.8 months
for the BRUKINSA arm and 2.9 months for the ibrutinib arm.2

The median follow-up time was 19.4 months.3

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

*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.


CI=confidence interval; CR=complete response; IRC=independent review committee; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; PR=partial response; VGPR=very good partial response.



Consistent responses with BRUKINSA
regardless of line of therapy


All subgroup analyses are exploratory and descriptive in nature.

The median follow-up time was 19.4 months.3

Responses were determined using modified IWWM-6 criteria.

§There were no CRs in either treatment arm.


CI=confidence interval; CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MR=minor response; ORR=overall response rate; PR=partial response; VGPR=very good partial response.



Consistent responses with BRUKINSA
regardless of mutation


All subgroup analyses are exploratory and descriptive in nature.

The median follow-up time was 19.4 months for Cohort 1
and 17.9 months for Cohort 2.3,6

Responses were determined using modified IWWM-6 criteria.

#There were no CRs in either treatment arm.


CI=confidence interval; CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MR=minor response; MUT=mutated; ORR=overall response rate; PR=partial response; VGPR=very good partial response; WHIM=WHIM syndrome-like somatic mutation; WM=Waldenström’s macroglobulinemia; WT=wild type.



DEEP AND SUSTAINED IgM REDUCTIONS
OVER TIME WITH BRUKINSA


Serum IgM levels are a marker of disease activity.4



DURABLE DISEASE CONTROL
WITH BRUKINSA


Sustained responses in patients who achieved
a response (CR+VGPR+PR)

Median duration of response (VGPR/CR)
was not reached in either treatment arm.3

The median follow-up time was 19.4 months.3

Consistent responses continue
with BRUKINSA

STUDY 003: Exploratory long-term analysis7

A Phase 1/2, open-label, multicenter, single-arm trial including 77 patients
with treatment-naïve and relapsed/refractory WM.††


Data were consistent with results observed in ASPEN (Study 302) and the
overall safety profile of BRUKINSA.7

Median follow-up time was 24 months in patients with treatment-naïve
WM and 36 months in patients with R/R WM.7

††Assessed by IRC using modified IWWM-6 criteria.

‡‡There was 1 CR in the study.


CI=confidence interval; CR=complete response; IRC=independent review committee; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MR=minor response; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory; VGPR=very good partial response; WM=Waldenström’s macroglobulinemia.

Flexible
Dosing
Dosing
Established
Safety Profile
Safety
Personalized
Patient Support
Patient Support