THE FIRST AND ONLY HEAD-TO-HEAD
TRIAL OF BTK INHIBITORS IN WM*

ASPEN (STUDY 302)

Brukinsa


A Phase 3, randomized, open-label, multicenter trial conducted globally across
61 sites comparing BRUKINSA with ibrutinib in 229 patients with WM1,2


2 cohorts were analyzed1,3

Cohort 1 (n=201)

Patients with MYD88MUT WM were randomized 1:1 to receive BRUKINSA or ibrutinib

Cohort 2 (exploratory; n=28)

Patients with MYD88WT WM received BRUKINSA


The primary endpoint of proportion of patients achieving a CR or VGPR was
assessed by IRC based on standard and modified response criteria from the
6th International Workshop on Waldenström’s Macroglobulinemia (IWWM-6).1


*Patients were enrolled from the United States, Europe, and Australia/New Zealand.


CR=complete response; IRC=independent review committee; MUT=mutated; VGPR=very good partial response; WM=Waldenström’s macroglobulinemia; WT=wild type.

ASPEN (STUDY 302) PATIENT DISPOSITION1,3,4


ELIGIBLE PATIENTS

• Histological diagnosis of WM
• Meeting ≥1 criterion for treatment initiation
• No prior BTK inhibitors

Brukinsa

Cohort 2 Rationale: Since major responses have not previously been observed in ibrutinib-treated patients with MYD88WT, patients found to have MYD88WT by gene sequencing (n=26) or those with unknown/inconclusive MYD88WT mutational status (n=2) were assigned to receive BRUKINSA in this separate single-arm exploratory analysis.5


BID=twice daily; BTK=Bruton’s tyrosine kinase; MUT=mutated; PD=progressive disease; QD=once daily; R=randomization; R/R=relapsed/refractory; TN=treatment naïve; WM=Waldenström’s macroglobulinemia; WT=wild type.

Baseline patient characteristics in
a range of patients

Patient characteristics:
Cohort 14


Baseline Patient Characteristics BRUKINSA
(n=102)
Ibrutinib
(n=99)
Median age 70 years (range: 45-87) 70 years (range: 38-90)
Age >75 years 33% 22%
Median time since diagnosis 4.4 years 4.9 years
Median prior regimens 1 (range: 0-8) 1 (range: 0-6)
Treatment naïve 19% 18%
Median lgM g/L 31.8 (range: 5.8-87) 34.2 (range: 2.4-108)
ECOG
0/1 94% 93%
Prognostic category
Low 17% 13%
Intermediate 37% 42%
High 46% 44%
Extramedullary disease 79% 74%
Prior ASCT 2.9% 1.0%
Genotype by NGS
MYD88L265P/CXCR4WT 89% 91%
MYD88L265P/CXCR4WHIM 11% 8%

Comorbidities: Cohort 14


Baseline Patient Characteristics BRUKINSA
(n=102)
Ibrutinib
(n=99)
Preexisting conditions
Atrial fibrillation/flutter 10% 8%
Hypertension 38% 43%

ASCT=autologous stem cell transplant; ECOG=Eastern Cooperative Oncology Group; NGS=next-generation sequencing; WHIM=WHIM syndrome-like somatic mutation; WT=wild type.



Powerful and
Sustained Responses
Efficacy
Established
Safety Profile
Safety
Personalized
Patient Support
Patient Support