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    Association details:
    Biomarker:CXCR4 mutation
    Cancer:Waldenstrom Macroglobulinemia
    Drug:Brukinsa (zanubrutinib) (BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    PPLC 2022
    Title:

    ASPEN: Long-Term Follow-up Results of a Phase 3 Randomized Trial of Zanubrutinib (ZANU) vs Ibrutinib (IBR) in Patients (PTS) with Waldenström Macroglobulinemia (WM)

    Published date:
    07/22/2022
    Excerpt:
    ASPEN is an open‑label, multicenter, randomized phase 3 study of zanubrutinib vs ibrutinib in patients with WM….CXCR4 mutation status was assessed retrospectively by NGS using residual DNA samples or duplicate bone marrow biopsy sample….In patients with CXCR4MUT confirmed by NGS, zanubrutinib demonstrated deeper and faster responses, as well as favorable PFS, compared with ibrutinib (Figure 5 and Table 2).
    Trial ID:
    ASPEN; 2016-002980-33
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2023
    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:
    cyclophosphamide + dexamethasone; dexamethasone
    DOI:
    10.1182/blood-2023-189130