THE FIRST AND ONLY HEAD-TO-HEAD
TRIAL OF BTK INHIBITORS IN WM*
ASPEN (STUDY 302)
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 analyzed1-4
Patients with MYD88MUT WM were randomized 1:1 to receive BRUKINSA or ibrutinib
- Initial Analysis: 19 months
- Long-Term Analysis: 44 months
Patients with MYD88WT WM received BRUKINSA
- Initial Analysis: 18 months
- Long-Term Analysis: 43 months
The primary endpoint of proportion of patients achieving a CR or VGPR in Cohort 1 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.2
BTK=Bruton’s tyrosine kinase; 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
ELIGIBLE PATIENTS
• Histological diagnosis of WM
• Meeting ≥1 criterion for treatment initiation
• No prior BTK inhibitors
† 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 12,6
| 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% |
| Caucasian | 86% | 96% |
| 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 12
| 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.
