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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Source:
Title:

A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study

Excerpt:
Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib….Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P = .09). MRRs were 77% and 78%, respectively....These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.
DOI:
doi: 10.1182/blood.2020006844
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Excerpt:
...Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met 2....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The Efficacy and Safety of Zanubrutinib, Dexamethasone and or Not Cyclophosphamide Regimen in Symptomatic Waldenstrom Macroglobulinnemia

Published date:
11/02/2023
Excerpt:
A total of 30 Patients with WM were enrolled in this study median age 67(36-89); 76.7% males, 15 patients were untreated, others were treated patients. IPSS assessment grade1 26.7%; grade2 16.7%; grade3 56.6%. 80.0% (24/30) patients with MYD88L265P mutation 17.6% (3/17) patients with CXCR4 mutation...95%of patients were progression-free at 6 months in 25 evaluable patients. ORR was 95% in those (24/25) received ZD/ZCD regimen more than 2 months...These results demonstrate that zanubrutinib, dexamethasone and or not cyclophosphamide are quickly effective in the treatment of WM, with more deeper response...
Secondary therapy:
dexamethasone; cyclophosphamide + dexamethasone
DOI:
10.1182/blood-2023-189130
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase II Trial of the Bruton Tyrosine-Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Waldenström Macroglobulinemia

Published date:
07/12/2021
Excerpt:
All mutation groups benefited from zanubrutinib treatment (MRR in patients with MYD88 L265P mutation, 73%...Zanubrutinib achieved a high rate of response that was durable and deep in R/R WM patients across all subgroups...
DOI:
10.1158/1078-0432.CCR-21-0539
Trial ID: