Blood:Phase 3 trial: Two sets of BTK inhibitors to treat Fahrenheit globulinemia!

Inhibition of Bruton tyrosine kinase (BTK) is the treatment of Waldenstr? m's macroglobulinemia, WM)
, Constantine S. Tam and others conducted a Phase 3 Aspen study comparing the efficacy and safety of the first generation of BTK inhibitor irutinib and the new highly selective BTK inhibitor Zanurutinib in patients with Fahrenheit globulinemia.
findings were published recently in the journal Blood.
201 patients with MYD88L265P mutations were randomly assigned to the Irutinib and Zanubrutinib groups by 1:1.
end point is a completely or very good partial mitigation (CR or VGPR) rate.
critical endpoints include major mitigation rates (MRRs), progressless survival rates (PFS), mitigation durations (DORs), disease burden, and safety.
199 patients received at least one dose of the study.
patients receive CR.
29 (28%) and 19 (19%) patients in the zanubrutinib and Irutinib groups received VGPR, respectively, but the differences between the two groups were not statistically significant (P-0.09);
did not reach the mid-level DOR and PFS, and the 18-month non-progress survival rates of the Irutini and Zanubrutinib groups were 84% and 85%, respectively.
in the Zanubrutinib group, the incidence of atrial fibrillation, bruising, diarrhea, perigeatre, bleeding, muscle spasms and pneumonia, as well as the incidence of adverse events that led to discontinuation of treatment, was lower.
Although the rates of level 3 infections were similar in both groups (1.2% and 1.1%/100 per month, respectively), the risk of decreased neutral granulocytes in patients treated with Zanubrutinib was higher.
In summary, the results of this study show that Zanubrutinib and Irutinib have significant efficacy in treating Fahrenheit globulinemia, but Zanubrutinib treatment has better quality of relief and reduced toxicity, especially cardiovascular toxicity, than Irutinib.
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