BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) a global
biotechnology company, today announced that the results of the
final progression free survival (PFS) analysis of the ALPINE trial
will be presented at a late-breaking oral presentation session at
the 64th American Society of Hematology (ASH) Annual Meeting in New
Orleans. ALPINE is a global Phase 3 trial comparing BRUKINSA
(zanubrutinib) with IMBRUVICA® (ibrutinib) in patients with
relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or
small lymphocytic leukemia (SLL). The results will be presented at
10:15 am CST during the late-breaking abstract session on Tuesday,
December 13, 2022 in the Ernest N. Morial Convention Center, Hall
E.
In this final PFS analysis, BRUKINSA achieved superior PFS
compared with ibrutinib, as assessed by both Independent Review
Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p
=.0024, for both investigator and IRC). The PFS results favored
zanubrutinib consistently across major pre-defined subgroups
including IGHV status and patients with del(17p)/TP53, regardless
of IRC or investigator assessment.
“BRUKINSA is the only BTK inhibitor to demonstrate superior
efficacy over ibrutinib in any treatment setting; The ALPINE trial
results demonstrate superiority for both PFS and ORR versus
ibrutinib in relapsed or refractory CLL/SLL,” said Mehrdad
Mobasher, M.D., M.P.H. Chief Medical Officer, Hematology at
BeiGene. “With nearly 30 months of follow up in this trial, we have
seen a very consistent safety and tolerability profile for BRUKINSA
and look forward to sharing detailed results from this analysis at
ASH.”
CLL is one of the most common types of leukemia, accounting for
about one-quarter of new cases of leukemiai The condition is
characterized by consecutive relapses, with response to therapy
ultimately determining clinical benefit, including survival.
At this pre-defined response analysis with a median follow up of
29.6 months, BRUKINSA was generally well-tolerated with a safety
profile consistent with previous reports. Overall discontinuation
rates were lower with BRUKINSA (26.3%) compared to ibrutinib
(41.2%), as well as discontinuations due to adverse events (16.2 vs
22.8%) or progressive disease (7.3 vs 12.9%).
Cardiac safety measures at this analysis favored BRUKINSA
compared with ibrutinib: the rate of atrial fibrillation/flutter in
the BRUKINSA arm remained low (5.2%) compared with ibrutinib
(13.3%) and there were zero grade 5 adverse events due to cardiac
disorders with BRUKINSA versus six in the ibrutinib arm.
Investor Events
- Sunday, December 11, 2022 - BeiGene will host an
ancillary event in New Orleans 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.
- Tuesday, December 13, 2022 - BeiGene will host a webcast
following the ALPINE late-breaker presentation at 2:00 pm CST.
BeiGene senior management along with invited medical experts will
review the presented data and join for a Q&A panel.
- Tuesday, December 13, 2022 – BeiGene will host a webcast
in Chinese at 6:00 pm CST / December 14, 2022 8:00 am China time to
capture Company presentations at ASH. BeiGene senior management
will review highlights of the presented data.
These events can be accessed live from the investors section of
BeiGene’s website at http://ir.beigene.com,
http://hkexir.beigene.com or https://sseir.beigene.com. Archived
replays will be posted for 90 days following the events.
About BRUKINSA
BRUKINSA 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 4,700 subjects in 35 trials in more than 30 countries and
regions. To date, BRUKINSA is approved in 60 markets, including the
United States, China, the European Union Great Britain, Canada,
Australia, South Korea, Switzerland, and additional international
markets.
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 to provide clinical benefit to patients
with CLL, the future development, regulatory filing and approval,
commercialization, and market access of BRUKINSA for CLL, the
potential commercial opportunity for BRUKINSA, and BeiGene’s plans,
commitments, aspirations, and goals under the heading 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.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC and
Janssen Biotech, Inc.
IMPORTANT U.S. SAFETY INFORMATION FOR
BRUKINSA (zanubrutinib)
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
i 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221122005444/en/
Investor: Kevin Mannix +1 240-410-0129 ir@beigene.com
Media: Kyle Blankenship +1 667 3515176 media@beigene.com
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