Final Report of a Phase II Study of Ibrutinib and Venetoclax in Previously Untreated Waldenström Macroglobulinemia - PubMed
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- #ibrutinib
- #venetoclax
- #Waldenström macroglobulinemia
- Phase II study evaluated ibrutinib and venetoclax in untreated Waldenström macroglobulinemia (WM).
- All patients had MYD88 mutations; 38% had CXCR4 mutations, and 9% had TP53 alterations.
- Study halted due to ventricular arrhythmias in 9% of patients, including two fatal events.
- Median treatment duration was 10 cycles (28 days each).
- VGPR/CR rate was 42%, lower in patients with CXCR4 (29%) or TP53 (25%) mutations.
- Median progression-free survival (PFS) was 36 months; 4-year OS was 91%.
- TP53 mutations linked to inferior PFS, TFS, and PFS-EOT; CXCR4 mutations did not affect outcomes.
- Combination therapy showed deep, durable responses, warranting further development in WM.