BeiGene has a good news!

On April 28, BeiGene issued an announcement that its product Baiyueze® (Zebutinib) vs.
Ibrutinib is used to treat adult relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or The phase 3 clinical trial of ALPINE in patients with small lymphocytic lymphoma (SLL) yielded positive results in the interim analysis.

It is understood that chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults, accounting for 30% of leukemias.
It is characterized by the accumulation of small mature lymphocytes in the blood, bone marrow and lymphatic tissues, which can cause lymphocytosis, Bone marrow leukemia cells are infiltrated and lymph nodes are enlarged.

According to statistics, in 2017, there were approximately 114,000 new cases worldwide.

Baiyueze® (Zebutinib) 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 drug It is used in combination with other therapies to treat a variety of B-cell malignancies.

It is worth mentioning that at present, in addition to the United States and China, there are more than 30 Beyueze® related listing applications submitted for multiple indications, covering the European Union and more than 20 other countries.

ALPINE is the second phase 3 head-to-head clinical trial of Baiyueze® versus Ibrutinib conducted by BeiGene.

It is reported that the clinical trial has completed enrollment of all 652 patients and is in progress.
The planned final analysis is expected to be carried out in 2022.
By then, the pre-established trial endpoints ORR and PFS will be included.

The published interim analysis trial was carried out in 415 patients who received at least 12 months of follow-up.

The results of the study showed that compared with Ibrutinib, Baiyueze® achieved ORR superiority, and the difference was statistically significant (p value=0.
0006); and after IRC evaluation, Baiyueze® achieved a higher ORR.

As of the data cutoff point for the interim analysis, data on the secondary endpoint of progression-free survival (PFS) in 652 patients are not yet mature.

However, the descriptive summary data of PFS shows an early trend in favor of Baiyueze®.

At the same time, the clinical trial reached the safety-related pre-set secondary endpoints.

Compared with Ibrutinib, Baiyueze® has a lower risk of atrial fibrillation or flutter events in patients, and the difference is statistically significant.

All in all, the safety of Baiyueze® is in line with the data previously observed in its clinical development projects.

This article is integrated from the "BeiGene WeChat Official Account".

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