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Although Bruton's tyrosine kinase (BTK) inhibitor has shown promising efficacy in patients with Waldenström's macroglobulinemia (WM), there are limited data on its use in Asian patient populations
.
This study evaluated the efficacy and safety of BTK inhibitors in Chinese patients with relapsed/refractory (R/R) WM for the first time
Zebutinib (Zanubrutinib) is a potent BTK inhibitor independently developed by BeiGene in China .
It was approved by the NMPA in June 2020 for the treatment of adult mantle cell lymphoma (MCL) that has received at least one treatment in the past.
), adult chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
.
This is a single-arm, multi-center phase II study that recruited R/R WM patients who had received at least one treatment regimen in the past and received oral zebutinib (160 mg, 2/day) daily until Progression of the disease or intolerable toxicity
.
The primary endpoint is the primary response rate (MRR) assessed by an independent committee
A: PFS of the total patient population; B: PFS grouped by genotype
A: PFS of the total patient population; B: PFS grouped by genotypeA total of 44 patients were recruited
.
After a median follow-up of 33.
After a median follow-up of 33.
Adverse events
Adverse eventsThe median progression-free survival and the median duration of major remissions have not yet been reached
.
The most common adverse events (AEs) of grade ≥3 requiring emergency treatment were decreased neutrophil count (3.
The median progression-free survival and the median duration of major remissions have not yet reached
In summary, Zebutinib has achieved a long-lasting and deep high remission rate in all subgroups of R/R WM patients, which is expected to bring positive benefits to WM patients
.
.
Zebutinib has achieved a long-lasting and deep high remission rate in all subgroups of R/R WM patients, and is expected to bring positive benefits to WM patients
Original source:
Gang An, et al.
A Phase II Trial of the Bruton Tyrosine -Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Relapsed / Refractory Waldenström Macroglobulinemia in this message
