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Kütüphanede Ara Ara
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New Indication: Zanubrutinib for Waldenstrom macroglobulinemia

New Indication: Zanubrutinib for Waldenstrom macroglobulinemia
Study:
  • Randomized, open-label Phase III trial (ASPEN)
  • WM pts requiring treatment at any line
  • Cohort 1: MYD88 L265P mutated pts => zanubrutinib 160 mg BID (n=102) vs. ibrutinib 420 mg daily (n=99)
  • Cohort 2: MYD88 WT or unknown => all received zanubrutinib (n=28)
Efficacy:
  • Cohort 1 => Major response: 77% vs. 78%; VGPR: 31% vs. 20%, PFS @ 18 mos: 85% vs. 84%
  • Cohort 2 => Major response: 50%
Safety:
  • Grade >= 3 AEs: Neutropenia (20% vs. 8%), thrombocytopenia (6% vs. 3%), hypertension (6% vs. 11%), atrial fibrillation (none vs. 4%), pneumonia (1% vs. 7%), hematuria (none vs. 2%)

Blood (2020) 136 (18): 2038–2050

Tam CS, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study

https://doi.org/10.1182/blood.2020006844

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