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▎WuXi AppTec content team editor
Zebrutinib is a BTK small molecule inhibitor independently developed by BeiGene scientists and is currently undergoing extensive clinical trials worldwide as a single agent and in combination with other therapies for the treatment of a variety of B-cell malignancies
.
Since new BTKs are synthesized in the human body, zebrutinib is designed to achieve sustained targeted inhibition
of BTK proteins by optimizing bioavailability, half-life, and selectivity.
With differentiated pharmacokinetics from other approved BTK inhibitors, zebrutinib inhibits malignant B cell proliferation
in multiple disease-related tissues.
Today, BeiGene announced that its Bruton's tyrosine kinase (BTK) small molecule inhibitor, BRUKINSA (zebrutinib), has achieved positive results in a global Phase 3 clinical trial called ALPINE, where zebrutinib has achieved progression-free survival (PFS) results in the treatment of chronic lymphocytic leukemia (CLL) compared with active control BTK inhibitors by an independent review committee (IRC) and investigators
.
Zebrutinib was generally well tolerated and the safety results shown in this analysis were consistent
with previous reports.
At present, the regulatory application for zebrutinib for the treatment of CLL is under review by the US FDA and is expected to receive a response
early next year.
Zebrutinib is a BTK small molecule inhibitor independently developed by BeiGene scientists and is currently undergoing extensive clinical trials worldwide as a single agent and in combination with other therapies for the treatment of a variety of B-cell malignancies
.
Since new BTKs are synthesized in the human body, zebrutinib is designed to achieve sustained targeted inhibition
of BTK proteins by optimizing bioavailability, half-life, and selectivity.
With differentiated pharmacokinetics from other approved BTK inhibitors, zebrutinib inhibits malignant B cell proliferation
in multiple disease-related tissues.
ALPINE is a randomized, global phase 3 clinical trial to evaluate zebrutinib compared with ibrutinib in patients
with previously treated relapsed or refractory CLL/small lymphocytic lymphoma (SLL).
The primary endpoint of the trial was the overall response rate (ORR), which was assessed first for non-inferiority and then for efficacy
.
In April, BeiGene announced the results of the study's final response evaluation, which was confirmed by IRC that zebrutinib showed better ORR
than the active control group.
Mehrdad Mobasher, MD, chief medical officer of BeiGene Hematology, and Master of Public Health, said this positive result further enriches the clinical evidence and validates zebrutinib's potential to bring new hope
to patients with CLL as a refractory disease.
This PFS analysis showed that zebrutinib was more effective than the active control in terms of progression-free survival and overall response rate
.
The company looks forward to sharing detailed findings with medical professionals and patients, and plans to present them at medical congresses and in
the professional literature.
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.
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