Accepted presentations to showcase broad and
deep development programs targeting B-cell and myeloid
malignancies
15 accepted abstracts, including three oral
presentations for cornerstone BTKi, BRUKINSA®, and promising Bcl-2
inhibitor, BGB-11417
BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced clinical and real-world data
accepted at the 64th American Society of Hematology (ASH) Annual
Meeting, scheduled for December 10-14, 2022, in New Orleans.
BeiGene is focused on developing innovative and affordable oncology
medicines to improve treatment outcomes and access for patients
worldwide.
Key presentations
- Phase 1 trial results demonstrating proof of concept for
BGB-11417, a novel B-cell lymphoma 2 (Bcl-2) inhibitor in chronic
lymphocytic leukemia/small lymphocytic leukemia;
- Long-term efficacy and safety data from the MAGNOLIA trial of
BRUKINSA (zanubrutinib) in patients with relapsed/refractory (R/R)
marginal zone lymphoma; and
- Updated results from a Phase 2 trial showing tolerability and
efficacy of zanubrutinib in patients with B-cell malignancies who
were intolerant to acalabrutinib.
“BeiGene has established a solid foundation in both the research
and development of innovative medicines for hematologic
malignancies,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical
Officer, Hematology at BeiGene. “At this year’s ASH meeting, we
look forward to sharing a wealth of data from our broad, global
development programs. We will showcase our deep expertise and drive
to innovate -- from the Phase 1 data for our novel Bcl2 inhibitor,
BGB-11417 and through numerous presentations demonstrating
meaningful clinical efficacy and a consistent safety profile for
BRUKINSA across several B-cell malignancies.”
Additional presentations highlight combinability and strength
of pipeline
- Preliminary safety and efficacy of zanubrutinib in combination
with lenalidomide in patients with R/R diffuse large B-cell
lymphoma;
- Multiple posters for Phase 1 studies with BGB-11417 as
monotherapy or in combination, showing promising efficacy in B-cell
and myeloid malignancies, along with a manageable safety profile;
and
- Safety and efficacy of zanubrutinib in combination with
zandelisib in patients with R/R follicular lymphoma or mantle cell
lymphoma.
Investor event
BeiGene will host an ancillary event in New Orleans on December
11 at 8:00 pm CST for investors and analysts attending ASH. BeiGene
senior management will review highlights of the presented data, and
special guests will join them for a Q&A panel. The event will
be webcast live and it can be accessed from the investors section
of BeiGene’s website at http://ir.beigene.com,
http://hkexir.beigene.com or https://sseir.beigene.com. An archived
replay will be posted for 90 days following the event.
Hematologic
Malignancy
Title
Presentation details
Oral
R/R Follicular Lymphoma
R/R Mantle Cell Lymphoma
Safety and Efficacy of the PI3Kδ Inhibitor
Zandelisib in Combination with the BTK Inhibitor Zanubrutinib in
Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) or
Mantle Cell Lymphoma (MCL)
#78
Date: 12/10/2022
Time: 10:45 AM
R/R Marginal Zone Lymphoma
Long-Term Efficacy and Safety of
Zanubrutinib in Patients With Relapsed/Refractory (R/R) Marginal
Zone Lymphoma (MZL): Final Analysis of the MAGNOLIA (BGB-3111-214)
Trial
#234
Date: 12/10/2022
Time: 3:15 PM
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
A Phase 1 Study With The Novel B-Cell
Lymphoma 2 (Bcl-2) Inhibitor BGB-11417 As
Monotherapy or in Combination With
Zanubrutinib (ZANU) in Patients (Pts) With CLL/SLL: Preliminary
Data
#962
Date: 12/12/2022
Time: 4:45 PM
Poster
B-Cell Malignancies
Efficacy and Safety of Zanubrutinib in
Japanese Patients With Mature B-Cell Malignancies
#1590
Date: 12/10/2022
Time: 5:30 - 7:30 PM
B-Cell Malignancies
Zanubrutinib in Acalabrutinib-Intolerant
Patients (Pts) with B-Cell Malignancies
#1587
Date: 12/10/2022
Time: 5:30 - 7:30 PM
R/R Diffuse Large B-Cell Lymphoma
Preliminary Safety and Efficacy of
Zanubrutinib in Combination With Lenalidomide in Patients With
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
#1627
Date: 12/10/2022
Time: 5:30 - 7:30 PM
R/R B-Cell Malignancies
Biomarker Analysis of Zanubrutinib and
Tislelizumab Combination Therapy in Patients with
Relapsed/Refractory B-Cell Malignancies
#1529
Date: 12/10/2022
Time: 5:30 - 7:30 PM
Acute Myeloid Leukemia
Preliminary Safety and Efficacy of
BGB-11417, a Novel BCL2 Inhibitor, in Combination With Azacitidine
in Patients With Acute Myeloid Leukemia (AML)
#1443
Date: 12/10/2022
Time: 5:30 - 7:30 PM
Mature B-cell Malignancies
A Phase 1 Study Evaluating the Safety,
Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity
of BCL2 Inhibitor BGB-11417 in Adult Patients With Mature B-cell
Malignancies: Preliminary Data
#2989
Date: 12/11/2022
Time: 6:00 - 8:00 PM
Multiple Myeloma
Preliminary Safety and Efficacy of a BCL-2
Inhibitor, BGB-11417, in Patients With Relapsed/Refractory Multiple
Myeloma Harboring t(11,14): A Non-randomized, Open-label, Phase
1b/2 Study
#3235
Date: 12/11/2022
Time: 6:00 - 8:00 PM
Relapsed/Refractory B-Cell
Malignancies
Genomic Characterization of Patients in
Phase 2 Study of Zanubrutinib in BTK Inhibitor-Intolerant Patients
With Relapsed/Refractory B-Cell Malignancies
#4176
Date: 12/12/2022
Time: 6:00 - 8:00 PM
Non-Hodgkin’s Lymphoma
Waldenstr�m Macroglobulinemia
A Phase 1 Study With the Novel B-Cell
Lymphoma 2 (Bcl-2) Inhibitor BGB-11417 As Monotherapy or in
Combination with Zanubrutinib (ZANU) in Patients (Pts) With
Non-Hodgkin’s Lymphoma (NHL) or Waldenstr�m macroglobulinemia (WM):
Preliminary Data
#4201
Date: 12/12/2022
Time: 6:00 - 8:00 PM
R/R Mantle Cell Lymphoma
Long-Term Outcomes of Second-Line vs
Later-Line Zanubrutinib Treatment in Patients With
Relapsed/Refractory MCL: An Updated Pooled Analysis
#2894
Date: 12/11/2022 Time: 6:00 - 8:00 PM
Online Only
RWE
Real-World Evidence (RWE) Studies
Supported By Hematologic Oncology FDA Approval: What Do They Look
Like
RWE
Development of Hypertension and Atrial
Fibrillation Following Diagnosis of B-Cell Malignancies – A
Retrospective Analysis of US MarketScan Insurance Claims
Database
About BRUKINSA
BRUKINSA (zanubrutinib) is a small-molecule inhibitor of
Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists
that is currently being evaluated globally in a broad clinical
program as a monotherapy and in combination with other therapies to
treat various B-cell malignancies. BRUKINSA was specifically
designed to deliver targeted and sustained inhibition of the BTK
protein by optimizing bioavailability, half-life, and selectivity.
With differentiated pharmacokinetics compared to other approved BTK
inhibitors, BRUKINSA has been demonstrated to inhibit the
proliferation of malignant B cells within a number of
disease-relevant tissues.
BRUKINSA is supported by a broad clinical program which includes
more than 4,500 subjects in 35 trials across 28 markets. To date,
BRUKINSA has received approvals covering more than 55 countries and
regions, including the United States, China, the EU, Switzerland,
Great Britain, Canada, Australia, and additional international
markets.
About BGB-11417
BGB-11417 is a highly potent and selective Bcl-2 inhibitor
designed to produce deeper and more sustained target
inhibition.
Compared with venetoclax, BGB-11417 exhibited greater potency
(>10-fold) and higher target selectivity and showed signs of
overcoming treatment resistance in pre-clinical studies and tumor
models i
BRUKINSA IMPORTANT SAFETY INFORMATION
AND U.S. INDICATIONS
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients
with hematological malignancies treated with BRUKINSA monotherapy.
Grade 3 or higher hemorrhage events including intracranial and
gastrointestinal hemorrhage, hematuria and hemothorax have been
reported in 3.4% of patients treated with BRUKINSA monotherapy.
Hemorrhage events of any grade occurred in 35% of patients treated
with BRUKINSA monotherapy.
Bleeding events have occurred in patients with and without
concomitant antiplatelet or anticoagulation therapy.
Co-administration of BRUKINSA with antiplatelet or anticoagulant
medications may further increase the risk of hemorrhage.
Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA
if intracranial hemorrhage of any grade occurs. Consider the
benefit-risk of withholding BRUKINSA for 3-7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Infections
Fatal and serious infections (including bacterial, viral, or
fungal) and opportunistic infections have occurred in patients with
hematological malignancies treated with BRUKINSA monotherapy. Grade
3 or higher infections occurred in 27% of patients, most commonly
pneumonia. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jiroveci pneumonia and other infections according to standard of
care in patients who are at increased risk for infections. Monitor
and evaluate patients for fever or other signs and symptoms of
infection and treat appropriately.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (26%),
thrombocytopenia (11%) and anemia (8%) based on laboratory
measurements, were reported in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 13% of patients, and
Grade 4 thrombocytopenia occurred in 3.6% of patients.
Monitor complete blood counts regularly during treatment and
interrupt treatment, reduce the dose, or discontinue treatment as
warranted. Treat using growth factor or transfusions, as
needed.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinoma, have
occurred in 14% of patients treated with BRUKINSA monotherapy. The
most frequent second primary malignancy was non-melanoma skin
cancer, reported in 8% of patients. Other second primary
malignancies included malignant solid tumors (4.0%), melanoma
(1.7%) and hematologic malignancies (1.2%). Advise patients to use
sun protection and monitor patients for the development of second
primary malignancies.
Cardiac Arrhythmias
Atrial fibrillation and atrial flutter were reported in 3.2% of
patients treated with BRUKINSA monotherapy. Patients with cardiac
risk factors, hypertension, and acute infections may be at
increased risk. Grade 3 or higher events were reported in 1.1% of
patients treated with BRUKINSA monotherapy. Monitor signs and
symptoms for atrial fibrillation and atrial flutter and manage as
appropriate.
Embryo-Fetal Toxicity
Based on findings in animals, BRUKINSA can cause fetal harm when
administered to a pregnant woman. Administration of zanubrutinib to
pregnant rats during the period of organogenesis caused
embryo-fetal toxicity including malformations at exposures that
were 5 times higher than those reported in patients at the
recommended dose of 160 mg twice daily. Advise women to avoid
becoming pregnant while taking BRUKINSA and for 1 week after the
last dose. Advise men to avoid fathering a child during treatment
and for 1 week after the last dose.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to a fetus.
Adverse reactions
The most common adverse reactions, including laboratory
abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847)
included decreased neutrophil count (54%), upper respiratory tract
infection (47%), decreased platelet count (41%), hemorrhage (35%),
decreased lymphocyte count (31%), rash (31%) and musculoskeletal
pain (30%).
Drug Interactions
CYP3A Inhibitors: When BRUKINSA is co-administered with a strong
CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For
coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA
dose to 80 mg twice daily.
CYP3A Inducers: Avoid coadministration with moderate or strong
CYP3A inducers.
Specific Populations
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
INDICATIONS
- BRUKINSA is a kinase inhibitor indicated for the treatment of
adult patients with mantle cell lymphoma (MCL) who have received at
least one prior therapy. This indication is approved under
accelerated approval based on overall response rate. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
- BRUKINSA is indicated for the treatment of adult patients with
Waldenstr�m’s macroglobulinemia (WM).
- BRUKINSA is indicated for the treatment of adult patients with
relapsed or refractory marginal zone lymphoma (MZL) who have
received at least one anti-CD20-based regimen. This indication is
approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
Please see full U.S. Prescribing Information at
www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient
Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D and medical affairs team of
approximately 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 subjects. Our
expansive portfolio is directed predominantly by our internal
colleagues supporting clinical trials in more than 45 countries and
regions. Hematology-oncology, and solid tumor targeted therapies,
and immuno-oncology are key focus areas for the Company, with both
monotherapies and combination therapies prioritized in our research
and development. BeiGene currently has three licensed medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Switzerland, Great Britain,
Canada, Australia, and additional international markets; and the
non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as
well as the poly adenosine diphosphate-ribose polymerase (PARP)
inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including Mirati Therapeutics, Seagen, and
Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor ociperlimab that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
oncology products across designated regions of China.
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more patients
worldwide. With a broad portfolio, we are expediting development of
our diverse pipeline of novel therapeutics through our internal
capabilities and collaborations. We are committed to radically
improving access to medicines for far more patients who need them.
Our growing global team of more than 9,000 colleagues spans five
continents, with administrative offices in Beijing, China;
Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
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 statements regarding
the potential for BRUKINSA or BGB-11417, alone or in combination,
to provide clinical benefit to patients with B-cell or myeloid
malignancies, the future development, regulatory filing and
approval, commercialization, and market access of BRUKINSA or
BGB-11417, and BeiGene’s plans, commitments, aspirations, and goals
under the headings “BeiGene Oncology” and “About BeiGene.” Actual
results may differ materially from those indicated in the
forward-looking statements as a result of various important
factors, including BeiGene's ability to demonstrate the efficacy
and safety of its drug candidates; the clinical results for its
drug candidates, which may not support further development or
marketing approval; actions of regulatory agencies, which may
affect the initiation, timing, and progress of clinical trials and
marketing approval; BeiGene's ability to achieve commercial success
for its marketed medicines and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual
property for its medicines and technology; BeiGene's reliance on
third parties to conduct drug development, manufacturing, and other
services; BeiGene’s limited experience in obtaining regulatory
approvals and commercializing pharmaceutical products and its
ability to obtain additional funding for operations and to complete
the development and commercialization of its drug candidates and
achieve and maintain profitability; and the impact of the COVID-19
pandemic on BeiGene’s clinical development, regulatory, commercial,
manufacturing, and other operations, as well as those risks more
fully discussed in the section entitled “Risk Factors” in BeiGene’s
most recent quarterly report on Form 10-Q, as well as discussions
of potential risks, uncertainties, and other important factors in
BeiGene's subsequent filings with the U.S. Securities and Exchange
Commission. All information in this press release is as of the date
of this press release, and BeiGene undertakes no duty to update
such information unless required by law.
i Nan Hu, Yunhang Guo, Hai Xue, Ye Liu, Yin Guo, Fan Wang,
Xiaomin Song, Ying Guo, Shuaishuai Chen, Haipeng Xu, Taichang
Zhang, Yanwen Ma, Xuebing Sun, Yuan Hong, Yutong Zhu, Aiying Xu,
Zhenzhen Cheng, Haimei Xing, Zhiwei Wang, Xuesong Liu, Lai Wang;
Abstract 3077: Preclinical characterization of BGB-11417, a potent
and selective Bcl-2 inhibitor with superior antitumor activities in
haematological tumor models. Cancer Res 15 August 2020; 80
(16_Supplement): 3077.
https://doi.org/10.1158/1538-7445.AM2020-3077
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version on businesswire.com: https://www.businesswire.com/news/home/20221103005526/en/
Investor Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Kathleen Cuca +1 551 222 6790 media@beigene.com
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