Express BeiGene BTK inhibitor wins third FDA indication

▎Editor of WuXi AppTec's content team On September 15, BeiGene announced that the US FDA has accelerated the approval of its Bruton's tyrosine kinase (BTK) inhibitor Baiyueze (Zebutinib) for therapeutic acceptance Adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have been treated with at least one anti-CD20 antibody
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The press release pointed out that this is the third approval of Baiyueze in the FDA and the first approval in the field of marginal zone lymphoma
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The FDA approval is based on the effectiveness results of two single-arm clinical trials.
The primary endpoint of these two trials is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC) based on the 2014 Lugano classification criteria
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The pivotal phase 2 clinical trial MAGNOLIA evaluated the efficacy of Baiyueze in R/R MZL patients who have received at least one anti-CD20 antibody treatment
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A total of 66 patients were enrolled in the study.
Based on the evaluation of CT scans, the ORR was 56% (95% CI: 43, 68), and the complete response (CR) rate reached 20%; based on the evaluation of priority PET-CT scans, the ORR was 67 % (95% CI: 54, 78), the CR rate was 26%
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When the median follow-up time was 8.
3 months, the median duration of response (DoR) had not yet been reached.
As of 12 months, 85% of patients who had achieved remission were still in continuous remission (95% CI: 67, 93)
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Remission was observed in all patients with MZL subtypes
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Another global phase 1/2 clinical study BGB-3111-AU-003 evaluated 20 patients with MZL
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Based on the evaluation of CT scan, the ORR obtained by Baiyueze was 80% (95% CI: 56, 94), and the CR rate was 20%
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At a median follow-up time of 31.
4 months, the median DoR had not yet been reached.
As of 12 months, 72% of patients who had achieved remission were still in continuous remission (95% CI: 40, 88)
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Baiyueze is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists.
It is currently undergoing extensive clinical trials worldwide as a single agent and combined with other therapies.
A B-cell malignant tumor
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Since new BTK will be continuously synthesized in the human body, Baiyueze's design achieves complete and continuous inhibition of BTK protein by optimizing bioavailability, half-life and selectivity
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With its differentiated pharmacokinetics, Baiyueze can inhibit the proliferation of malignant B cells in multiple disease-related tissues
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The lead investigator of the MAGNOLIA trial, Dr.
Stephen Opat, M.
D.
, head of hematology at Monash University, Australia, and director of clinical hematology at Monash Hospital, commented: "BTK plays a key role in the B cell receptor signaling pathway and is also marginal zone lymphoma.
A major cause of formation
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In the MAGNOLIA trial, Baiyueze showed an impressive total remission rate and complete remission rate, and remission was observed in all MZL subtypes
.

In addition, this new generation of BTK inhibitors It also showed good tolerability in these tested patients, and the incidence of patients discontinuing treatment due to adverse reactions is low
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We believe that Baiyueze can bring clinical significance to patients with relapsed/refractory marginal zone lymphoma Benefit
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”Reference materials: [1] The US FDA has granted accelerated approval to Baiyueze® (Zebutinib) for the treatment of relapsed or refractory marginal zone lymphoma.
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