BeiGene's BRUKINSA? Zebratinib is approved by the European Commission for the treatment of adults with chronic lymphocytic leukemia

BeiGene (NASDAQ: BGNE; HKEx code: 06160; SSE code: 688235) is a global biotechnology company
.
The company announced on November 17 that the European Commission (EC) has approved BRUKINSA ® (zebrutinib) for the treatment of adults with treatment-naïve (TN) or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL
).

Mehrdad Mobasher, M.
D.
, Chief Medical Officer of BeiGene's Hematology, and Master of Public Health, said, "This approval is an important milestone for CLL patients and their physicians, providing them with a new, chemotherapy-free alternative to existing BTK inhibitors
.
Across patient subgroups, BRUKINSA ® demonstrated consistent benefits
regardless of patient risk status.
Based on this, we believe BRUKINSA ® is expected to be the treatment priority for
patients with newly diagnosed and relapsed/refractory CLL.
"

The EC approval is based on positive results
from two Phase 3 clinical trials.
The two trials were the SEQUOIA trial (NCT03336333) in previously untreated patients with CLL and the ALPINE trial (NCT03734016)
in patients with R/R CLL.
In both trials, BRUKINSA ® demonstrated efficacy in both trials compared with bendamustine plus rituximab (B+R) for first-line CLL or with ibrutinib for R/R CLL treatment
.
BRUKINSA ® is the only BTK inhibitor evaluated by an independent review committee (IRC) to be superior to ibrutinib in R/R CLL with overall response rates (ORRs) of 80.
4% and 72.
9% (bilateral p-value = 0.
0264) ^[1].

In addition, more patients treated with BRUKINSA ® remained in remission after one year compared with ibrutinib (78 versus 90 percent) ^[1].

The adverse events that occurred in both trials were consistent
with the overall safety profile of BRUKINSA ®.
Following the submission of the application, BeiGene announced in October that BRUKINSA ® had achieved superior results
over ibrutinib in end-of-life analysis of R/R CLL in a final analysis of the ALPINE head-to-head trial.

Professor Clemens Wendtner, Head of Hematology-Oncology at the Munich Clinic at the University of Munich Academic Hospital, said: "BRUKINSA ® has shown clinically significant improvements and is a new generation of BTK inhibitors that surpasses the first generation of BTK inhibitors, and has been shown to have significant advantages
in efficacy and safety.
Because patients with CLL require long-term treatment, it is critical
to ensure the safety and tolerability of the drugs used in this patient population.
Coupled with flexible dosing options, this approval provides a transformative treatment option
for patients with CLL, one of the most common types of adult leukemia.
"

Gerwin Winter, senior vice president and head of Europe at BeiGene, said, "We are pleased
with the significant progress we have made towards BRUKINSA ® reaching patients with hematological oncology worldwide.
With this important approval, we will embrace the opportunity to further expand BeiGene's presence in Europe and bring this innovative treatment option to CLL patients
across Europe.
" "

BRUKINSA ® is currently approved in the EU for the treatment of adult patients with Waldenstrom macroglobulinemia (WM) who have previously received at least one therapy, or as first-line therapy for WM patients who are not candidates for immunochemotherapy, and for the treatment of marginal zone lymphoma (MZL) in adults who have previously received at least one anti-CD20 therapy
.

In Europe, BeiGene has been reimbursed for BRUKINSA ® for WM in Austria, Belgium, Denmark, England and Wales, Germany, Iceland, Ireland, Italy, Scotland, Spain, Switzerland and the Netherlands, and other EU countries are advancing the process of integrating the drug into their reimbursement systems
.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a slow-progressing, life-threatening, and incurable adult cancer that is a mature B-cell malignancy that accumulates in peripheral blood, bone marrow, and lymphoid tissue by abnormal leukemia B lymphocytes (a type of white blood cell) originating in the bone marrow [2],[^3],[4].

CLL is one of the most common types of leukemia, accounting for about a quarter of new cases of leukemia ^[5].

The incidence of CLL in Europe is estimated at 4.
92 cases per 100,000 people per year [^6],[7].

About BRUKINSA ®

BRUKINSA ® is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) 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
.
BRUKINSA's ® design achieves targeted, sustained inhibition
of BTK proteins by optimizing bioavailability, half-life and selectivity.
With differentiated pharmacokinetic profiles with other approved BTK inhibitors, BRUKINSA ® has been shown to inhibit malignant B cell proliferation
in multiple disease-associated tissues.

BRUKINSA ® has undertaken extensive global clinical development programs, currently conducting 35 trials in more than 25 countries and territories around the world, with a total enrollment of more than 4,700 subjects
.
To date, BRUKINSA ® has been approved
in 58 markets, including the United States, China, the European Union and the United Kingdom, Canada, Australia, South Korea, Switzerland and other international markets.

References

       [1] BRUKINSA® (zanubrutinib).
Summary of product characteristics; 2022.

       [2] National Cancer Institute.
Surveillance, Epidemiology, and End Results Program.
Cancer Stat Facts: Leukemia —Chronic Lymphocytic Leukemia (CLL).
Accessed October 4,2021.
https://seer.
cancer.
gov/statfacts/html/clyl.
html

       [3] Aster JC, Freedman A.
Non-Hodgkin lymphomas and chronic lymphocytic leukemias.
In: Aster JC, Bunn HF (eds.
).
Pathophysiology of Blood Disorders.
2nd ed.
McGraw-Hill Education; 2017:chap

       [4] American Cancer Society.
What is chronic lymphocytic leukemia? Updated May 10, 2018.
Accessed December 6, 2020.

[5] Yao Y, Lin X, Li F, Jin J, Wang H.
The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019.
Biomed Eng Online.
2022 Jan 11; 21(1):4.
doi: 10.
1186/s12938-021-00973-6.
PMID: 35016695; PMCID: PMC8753864.

       [6] Miranda-Filho, A.
, et al.
, Epidemiological patterns of leukaemia in 184 countries: a population-based study.
The Lancet Haematology, 2018.
5(1): p.
e14-e24.

       [7] Sant, M.
, et al.
, Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project.
Blood, 2010.
116(19): p.
3724-34.