Express first-line treatment of leukemia, BeiGene BTK inhibitor reduces the risk of disease progression by 58%

▎Editor of WuXi AppTec's content team On November 4, 2021, BeiGene announced that its Bruton's tyrosine kinase (BTK) inhibitor Baiyueze (Zebutinib, English trade name Brukinsa) will be on the front line Positive results were obtained in phase 3 clinical trials for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
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Compared with the active control group, zebutinib monotherapy reduced the patient's risk of disease progression or death by 58%
.

Baiyueze is a small molecule inhibitor of BTK independently developed by BeiGene scientists.
Since new BTK will be continuously synthesized in the human body, Baiyueze's design can optimize the bioavailability, half-life and selectivity to achieve BTK resistance.
Complete and continuous inhibition of protein
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With its differentiated pharmacokinetics, Baiyueze can inhibit the proliferation of malignant B cells in multiple disease-related tissues
.

Recently, it received accelerated approval from the US FDA for the treatment of adult patients with relapsed/refractory marginal zone lymphoma.
This is also the third FDA approval for Baiyueze
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In the phase 3 clinical trial, the interim analysis showed that Baiyueze reached the primary clinical endpoint in the treatment of newly treated CLL patients
.

The independent monitoring committee (IRC) and the investigator's evaluation found that compared with the active control group, Baiyueze significantly prolonged the progression-free survival of patients (HR=0.
42, p<0.
0001)
.

In addition, when the median follow-up time was 26.
2 months, as assessed by IRC, the overall response rate (ORR) of the Baiyueze group was 94.
6%, and that of the active control group was 85.
3%
.

It is important to point out that the key safety index observed in this trial-the incidence of atrial fibrillation is low, which is consistent with the data results shown in previous studies
.

Dr.
Huang Weijuan, Chief Medical Officer of BeiGene Hematology, said: "This test result shows that Baiyueze can improve the treatment effect of CLL patients
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The data that will be presented at the ASH annual meeting this year makes us more convinced of the difference of Baiyueze.
The chemical design can bring clinical benefits to patients with hematological tumors, including those who discontinue treatment while using other BTK inhibitors
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We look forward to sharing more details about the clinical progress of our hematology product portfolio in Atlanta with the medical community
.

"Reference: [1] BeiGene to Present Clinical Data on BRUKINSA in Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting.
Retrieved November 4, 2021, from https://ir.
beigene.
com/news-details/?id=4430893a -fb68-4d3c-a0a6-3e2383d854d7[2] 396 SEQUOIA: Results of a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine + Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphocytic/Small Lymphocytic Lymphoma (C ).
Retrieved November 4, 2021, from https://ash.
confex.
com/ash/2021/webprogram/Paper148457.
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.

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in the
article .
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.

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