BRUKINSA? (zebrutinib) vs. Eco? A Phase 3 clinical trial (ibrutinib) for chronic lymphocytic leukemia yielded positive results in an end-of-life analysis of progression-free survival

BEIJING, China, Cambridge, Massachusetts and Basel, Switzerland, Oct.
12, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEx code: 06160; SSE: 688235) is a global biotechnology company focused on developing innovative, affordable anti-tumor drugs for patients around the world, improving patient outcomes and increasing drug access
.
The Company today announced that in a final analysis of the global Phase 3 ALPINE trial, BRUKINSA ^® (zebrutinib) compared with Ecol ^® (ibrutinib) achieved a favorable outcome
of progression-free survival (PFS) in 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.

Mehrdad Mobasher, M.
D.
, and MPH, Chief Medical Officer of Hematology, BeiGene, said, "This positive result further complements our clinical evidence and validates the potential of zebrutinib to bring new hope
to patients with chronic lymphoblastic leukemia (CLL), a refractory disease.
This end-stage PFS analysis showed that zebrutinib was more effective than ibrutinib in terms of progression-free survival and overall response rate
.
We look forward to sharing detailed findings with healthcare professionals and patients, and plan to present them at medical congresses and in
the professional literature.
" "

BeiGene's application for marketing authorization for a new indication for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) in the United States is currently under review, and the FDA has a
target date for January 20, 2023.

About ALPINE clinical trials

ALPINE is a randomized, global phase 3 clinical trial (NCT03734016) to evaluate BRUKINSA ^® (zebrutinib) versus Eco (ibrutinib) for the treatment of previously treated patients
with relapsed or refractory chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma ^(SLL).
® 。 In this trial, a total of 652 patients (60% in Europe, 17% in the US, 14% in China, and 9% in New Zealand and Australia) were randomized to receive zebrutinib (160 mg orally twice daily) and ibrutinib (420 mg orally once daily) until the patient developed disease progression or unacceptable toxicity
.

The primary endpoint of the trial was overall response rate (ORR) and presupposed that zebrutinib was not inferior to ibrutinib
.
In the analysis of ORR, the investigators and the Independent Review Committee (IRC) evaluated remission in patients with CLL based on the International Working Group on Chronic Lymphocytic Leukemia (iwCLL) guidelines (revised 2008) (but the evaluation criteria for patients with treatment-associated lymphocytosis CLL were adjusted) and the Lugano non-Hodgkin lymphoma classification criteria assessed remission
in patients with SLL patients.
ORRs evaluated by investigators and IRCs use pre-specified graded assessment tests to assess non-inferiority first, followed by efficacy
.
Key secondary endpoints of the study included progression-free survival (PFS) and atrial fibrillation or atrial flutter event rates; Other secondary endpoints included time to sustained response (DoR), overall survival (OS), and adverse event rate
.
In April, BeiGene announced the results of the final mitigation evaluation of the study, which was confirmed by IRC that zebrutinib showed a superior ORR
to ibrutinib.

About BRUKINSA^®

BRUKINSA ^® (zebrutinib) is a Bruton's tyrosine kinase (BTK) small molecule inhibitor independently developed by BeiGene scientists and is currently undergoing extensive clinical trials worldwide as a monotherapy 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.

Zebrutinib has conducted an extensive global clinical development program and has now conducted 35 trials in 28 markets worldwide, with a total enrollment of more than 4,500 participants
.
To date, zebrutinib has been approved
in more than 55 countries and regions, including the United States, China, the European Union, the United Kingdom, Switzerland, Canada, Australia and other international markets.

About BeiGene 

BeiGene is a global biotechnology company focused on developing and commercializing innovative, affordable anti-oncology drugs for patients worldwide, improving patient outcomes and
accessibility.
Through strong independent research and development capabilities and external strategic cooperation, we continue to accelerate the development of diversified and innovative drug
pipelines.
We are committed to improving access to medicines for more patients around the world
.
BeiGene has a team of more than 9,000 people on five continents and major offices
in Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland.
For more information, please visit _istranslated="1">.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including regarding the results of the PFS terminal analysis of the ALPINE Phase 3 trial and the potential implications of these data for patients, BeiGene's plans to publish the data at medical conferences and in the professional literature, The timing of the regulatory review and potential regulatory approval of zebrutinib as a new treatment option for patients with CLL, BeiGene's progress in advancing the expected clinical development of zebrutinib, regulatory milestones and commercialization, and BeiGene's plans, commitments, aspirations and goals
under "About BeiGene.
" Actual results may differ materially from
those in the forward-looking statements due to a variety of important factors.
These factors include: BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; The clinical results of its drug candidates may not support further development or marketing approval; Regulatory actions may affect the initiation, timeline and progress of clinical trials and drug marketing approval; BeiGene's ability to achieve commercial success of marketed drugs and drug candidates (if approved); BeiGene's ability to obtain and maintain intellectual property protection for its medicines and technologies; BeiGene's reliance on third parties for drug development, manufacturing and other services; BeiGene's limited experience in obtaining regulatory approval and commercialization of pharmaceutical products, and its ability to obtain further working capital to complete the development and commercialization of drug candidates and achieve and remain profitable; the impact of the global pandemic on BeiGene's clinical development, regulatory, commercial operations, manufacturing and other businesses; and the risks discussed more fully in the "Risk Factors" section of BeiGene's most recent quarterly report on Form 10-Q; and a discussion
of potential risks, uncertainties and other material factors in BeiGene's post-period filings with the U.
S.
Securities and Exchange Commission.
All information in this press release is current only as of the date of this press release and BeiGene is under no obligation to update such information
unless required by law.

*Eco ^® is a registered trademark
of Pharmacyclics LLC and Janssen Biotech, Inc.