POWERFUL AND
DURABLE 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
Initial analysis (19 months)2
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.3
The median follow-up time was 19.4 months.2
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; WM=Waldenström’s macroglobulinemia.
Consistent responses with BRUKINSA
regardless of line of therapy
Initial analysis (19 months)2
All subgroup analyses are exploratory and descriptive in nature.
The median follow-up time was 19.4 months.2
‡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
Initial analysis (19 and 18 months, respectively)2,6
All 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 2.2,6
¶Responses were determined using modified IWWM-6 criteria.
#There were no CRs in either treatment arm.
CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MUT=mutated; PR=partial response; VGPR=very good partial response; WHIM=WHIM syndrome-like somatic mutation; WT=wild type.
RESPONSES CONTINUED OVER TIME REGARDLESS OF MUTATION
Long-term analysis (44 months and 43 months, respectively)7
All analyses are exploratory and descriptive in nature.
The median follow-up time was 44.4 months for Cohort 1 and 42.9 months for Cohort 2.7
**Responses were determined using modified IWWM-6 criteria.
††In Cohort 2, 1 patient demonstrated a CR at 42.9-month follow-up.
CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MRR=major response rate; MUT=mutated; PR=partial response; VGPR=very good partial response; WT=wild type.
DURABLE DISEASE CONTROL
WITH BRUKINSA
Sustained responses in patients who achieved
a response (CR+VGPR+PR)
Initial analysis (19 months)2
All subgroup analyses are exploratory and descriptive in nature.
Median duration of response (VGPR/CR)
was not reached in either treatment arm.2
The median follow-up time was 19.4 months.2
At 2 years: Event-free duration of CR+VGPR for BRUKINSA was higher (90.6%; range 73.6%, 96.9%) vs ibrutinib (79.3%; range 53.5%, 91.8%)7
CI=confidence interval; CR=complete response; PR=partial response; VGPR=very good partial response.
CONSISTENT RESPONSES CONTINUE WITH BRUKINSA
STUDY 003: A PHASE 1/2 SUPPORTIVE STUDY8
A Phase 1/2, open-label, multicenter, single-arm trial including 77 patients with treatment-naïve and relapsed/refractory WM‡‡
Data are consistent with results observed in ASPEN (Study 302) and the overall safety profile of BRUKINSA.8
Median follow-up time was 24 months in patients with treatment-naïve WM and 36 months in patients with R/R WM.8
‡‡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.
