BRUKINSA patients can call the myBeiGene® patient support program to talk to a dedicated nurse: 1-833-BEIGENE (1-833-234-4363)
Adults with WM rapidly achieved high response rates regardless of line of therapy or mutation.
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.
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.
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.
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.
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.
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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.
These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
BRUKINSA is a prescription medicine used to treat adults with:
It is not known if BRUKINSA is safe and effective in children.
Please see full Prescribing Information including Patient Information.