BRUKINSA® (zanubrutinib) continues to show
progression free survival (PFS) benefit compared with ibrutinib in
extended follow-up of patients with relapsed/refractory (R/R)
chronic lymphocytic leukemia and small lymphocytic lymphoma
(CLL/SLL) in the ALPINE trial
Results of several studies reinforce the
favorable efficacy and safety profile for BRUKINSA, including in
patients switching from other Bruton’s tyrosine kinase (BTK)
inhibitors
Presentations highlight promising clinical
activity of sonrotoclax, BeiGene’s investigational B-cell lymphoma
2 (BCL2) inhibitor, in three Phase 1/2 studies
First presentation of data from ongoing,
first-in-human study of BeiGene’s novel BTK degrader, BGB‑16673,
demonstrating a tolerable safety profile and notable clinical
responses in heavily pre-treated patients
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced the presentation of new data
across a range of assets and blood cancers at the upcoming 65th
American Society of Hematology (ASH) Annual Meeting and Exposition,
taking place December 9-12 in San Diego, California. BeiGene has 24
abstracts accepted at ASH, with three abstracts scheduled for oral
presentations.
“Our data at ASH showcase BeiGene’s leadership in the treatment
of blood cancers, with promising clinical advances across our
pipeline. Sonrotoclax, our BCL2 inhibitor, and BGB-16673, our
BTK-degrader, both have very compelling results to date, and
numerous presentations continue to underscore BRUKINSA as a
potential best-in-class BTK inhibitor,” said Mehrdad Mobasher,
M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “In
addition to the sustained progression free survival benefit we see
for BRUKINSA over ibrutinib with more than three years of follow-up
for the ALPINE trial, we are sharing results of several studies
that reinforce BRUKINSA’s safety and efficacy profile relative to
other members of the class. At BeiGene, we are committed to
advancing promising treatment options for patients living with
blood cancers.”
Furthering Leadership in BTK Inhibition with BRUKINSA
BRUKINSA continues to show sustained PFS benefit versus
ibrutinib in the global Phase 3 ALPINE trial of patients with R/R
CLL/SLL with this longer follow up. Durable PFS was observed across
major subgroups, including in the high-risk 17p deletion/TP53
mutated patient population. In addition, the overall safety and
tolerability profile was consistent with previous ALPINE analyses,
including persistently lower rates of cardiovascular events
reported with BRUKINSA. Based on these results among patients
receiving more than three years of treatment, BRUKINSA continues to
be a more efficacious and better-tolerated treatment than ibrutinib
for patients with R/R CLL/SLL. (Abstract #202, oral
presentation)
Data from Waldenstr�m Macroglobulinemia patients treated with
and tolerating ibrutinib on the Phase 3 ASPEN trial who switched to
receive BRUKINSA on a long-term extension study demonstrate
generally improved safety and deepening of responses with the
switch to BRUKINSA. (Abstract #3043)
In an ongoing Phase 2 study, patients with B-cell malignancies
experiencing intolerance to acalabrutinib were transitioned to
BRUKINSA, with favorable results. The data suggest that for
patients intolerant of acalabrutinib, switching to BRUKINSA leads
to better tolerance (rare recurrence of adverse events) while
maintaining or deepening response. (Abstract #3279)
Advancing BeiGene’s Pipeline of Next-Generation Blood Cancer
Treatments
In an ongoing Phase 1/2 study, patients with treatment-naïve
(TN) CLL/SLL were treated with sonrotoclax in combination with
BRUKINSA. The combination was observed to be well tolerated; no
cases of tumor lysis syndrome (TLS) were observed. There was a 100%
response rate, including deep responses, and at time of follow-up
no patient experienced disease progression (100% PFS). (Abstract
#327, oral presentation) Based on these results, a Phase 3 study
assessing a fixed duration combination of sonrotoclax and BRUKINSA
is planned.
Sonrotoclax has also been well tolerated with high response
rates as monotherapy in a continuing Phase 1 study in patients with
R/R marginal zone lymphoma (MZL). (Abstract #3032)
Sonrotoclax was also evaluated in combination with dexamethasone
in patients with R/R multiple myeloma (MM) harboring t(11;14) at
doses up to 640 mg. Promising initial data indicate the combination
is safe and efficacious, with the majority of patients across all
dose levels achieving clinical response, including deep responses.
Further investigations in this setting are ongoing. The US Food and
Drug Administration recently granted Orphan Drug Designation to
sonrotoclax for treatment of multiple myeloma. (Abstract #1011,
oral presentation)
The first presentation of data from an ongoing, first-in-human
study of BeiGene’s novel, orally available BTK-targeted chimeric
degradation activation compound (CDAC), BGB-16673, demonstrates a
tolerable safety profile and notable clinical responses that are
durable at this clinical cut off in heavily pretreated patients
with B-cell malignancies, including those with BTKi-resistant
disease. (Abstract #4401)
More details on BeiGene’s abstracts are available in the ASH
program.
Raising Awareness Around the Importance of Mental Health and
Cancer Care
BeiGene will host its second annual event at ASH focused on the
mental health of people with cancer. The event is titled “Mental
Health First Aid: Bridging Cancer Centers and Community Partners to
Help Meet Acute Needs,” and it will take place on Friday, December
8 from 2:00 – 4:00 PM PT at the San Diego Wine and Culinary Center,
Fallbrook Cellar, 200 Harbor Drive, San Diego, California. To learn
more about this event and BeiGene’s “Talk About It" initiative,
please visit https://www.cancerandmentalhealth.com/.
BeiGene Presentation and Panel Event for Investors and
Analysts
BeiGene will host an event in San Diego on Sunday, December 10
at 8:00 pm PST for investors and analysts attending ASH. BeiGene
senior management and invited speakers will review BeiGene’s
pipeline and highlights of the presented data, followed by a
Q&A panel. The event can be accessed live from the Investors
section of BeiGene’s website at https://ir.beigene.com/,
http://hkexir.beigene.com, or https://sseir.beigene.com. Archived
replays will be posted for 90 days following the event.
For more information on the BeiGene abstracts, see
below:
Abstract Title
Abstract #
Presentation Time (PST)
Lead Author
BRUKINSA® (zanubrutinib)
Extended Follow-up of ALPINE
Randomized Phase 3 Study Confirms Sustained Superior
Progression-Free Survival of Zanubrutinib Versus Ibrutinib for
Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia and
Small Lymphocytic Lymphoma
202
Oral
Saturday, December 9,
2:00‑3:30 PM
J. Brown
Broad Superiority of Zanubrutinib
Over Bendamustine + Rituximab Across Multiple High-Risk Factors:
Biomarker Subgroup Analysis in the Phase 3 SEQUOIA Study in
Patients with Treatment-Naive Chronic Lymphocytic Leukemia /Small
Lymphocytic Lymphoma without del(17p)
1902
Poster
Saturday, December 9, 5:30‑7:30
PM
L. Xu
Acquired Mutations in Patients
with Relapsed/Refractory Chronic Lymphocytic Leukemia That
Progressed in the ALPINE Study
1890
Poster
Saturday, December 9, 5:30‑7:30
PM
J. Brown
Zanubrutinib in
Acalabrutinib-Intolerant Patients with B-Cell Malignancies
3279
Poster
Sunday, December 10, 6:00‑8:00
PM
M. Shadman
Clinical Outcomes in Patients
with Waldenstr�m Macroglobulinemia Receiving Ibrutinib on the Phase
3 ASPEN Study ≥1 Year After Transitioning to Zanubrutinib
3043
Poster
Sunday, December 10, 6:00‑8:00
PM
R. Garcia‑Sanz
Indirect Comparison of Efficacy
of Zanubrutinib Versus Orelabrutinib in Patients with Relapsed or
Refractory Mantle Cell Lymphoma: An Updated Analysis with Long-Term
Follow up
1682
Poster
Saturday, December 9, 5:30‑7:30
PM
Y. Song
A Phase 4, observational study
evaluating the efficacy and safety of the Bruton tyrosine kinase
inhibitor zanubrutinib in patients with Waldenstr�m
macroglobulinemia
6171
Online abstract
E. Kingsley
Genomic landscape of ibrutinib-
and/or acalabrutinib-intolerant patients with B-cell malignancies
treated with zanubrutinib in a Phase 2 study
6510
Online abstract
L. Xu
Sonrotoclax (BGB-11417)
Combination Treatment with
Sonrotoclax (BGB-11417), a Second-Generation BCL2 Inhibitor, and
Zanubrutinib, a Bruton Tyrosine Kinase (BTK) Inhibitor, Is Well
Tolerated and Achieves Deep Responses in Patients with
Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma: Data from an Ongoing Phase 1/2 Study
327
Oral
Saturday, December 9,
4:00‑5:30 PM
C. Tam
Sonrotoclax (BGB-11417) in
Combination with Dexamethasone for the Treatment of
Relapsed/Refractory Multiple Myeloma with t(11;14): Safety,
Efficacy, and Determination of Recommended Phase 2 Dose
1011
Oral
Monday, December 11, 4:30‑6:00
PM
H. Quach
Monotherapy with
Second-Generation BCL2 Inhibitor Sonrotoclax (BGB-11417) Is Well
Tolerated with High Response Rates in Patients with
Relapsed/Refractory Marginal Zone Lymphoma: Data from an Ongoing
Phase 1 Study
3032
Poster
Sunday, December 10, 6:00‑8:00
PM
A. Tedeschi
BTK-CDAC (BGB-16673)
First Results from a Phase 1,
First-in-Human Study of the Bruton’s Tyrosine Kinase Degrader
Bgb-16673 in Patients with Relapsed or Refractory B-Cell
Malignancies (BGB-16673-101)
4401
Poster
Monday, December 11, 6:00‑8:00
PM
J. Seymour
Tislelizumab (BGB-A317-210)
Tislelizumab, an Anti-PD1
Antibody, in Patients with Relapsed/Refractory Classical Hodgkin
Lymphoma in Tirhol BGB-A317-210: A Prospective Multicenter Lysa
Phase 2 Study Conducted in Western Countries
1717
Poster
Saturday, December 9, 5:30‑7:30
PM
H. Ghesquières
Health Economics and Outcomes
Research
Health-Related Quality of Life in
Patients with Relapsed/Refractory Follicular Lymphoma Treated with
Zanubrutinib+ Obinutuzumab Versus Obinutuzumab Monotherapy: The
Rosewood Trial
1674
Poster
Saturday, December 9, 5:30‑7:30
PM
J. Trotman
Recent Patterns of Care with BTK
Inhibitors and Distribution of Social Determinants of Health Among
Patients with CLL/SLL in the US Community Setting
2413
Poster
Saturday, December 9, 5:30‑7:30
PM
D. Andorsky
Toxicity, Progression-Free
Survival, and Quality of Life of Patients Treated with Zanubrutinib
Versus Ibrutinib: A Q-TWiST Analysis from the ALPINE Study in
Relapsed or Refractory Chronic Lymphocytic Leukemia
1909
Poster
Saturday, December 9, 5:30‑7:30
PM
V. Levy
Number Needed to Treat Analyses
of Zanubrutinib in Relapsed/Refractory Chronic Lymphocytic
Leukemia
2337
Poster
Saturday, December 9, 5:30‑7:30
PM
A. Chanan‑Khan
Similar Efficacy of Ibrutinib
Arms across ALPINE and ELEVATE-RR Trials in Relapsed/Refractory
Chronic Lymphocytic Leukemia: A Matching-Adjusted Indirect
Comparison
4655
Poster
Monday, December 11, 6:00‑8:00
PM
M. Shadman
Impact of Real-World Treatment
Sequencing Patterns on Time to Next Treatment among Patients with
Chronic Lymphocytic Leukemia in the United States
5143
Poster
Monday, December 11, 6:00‑8:00
PM
A. Chanan‑Khan
Real-World Evaluation of
Treatment Discontinuation and Healthcare Resource Utilization in
Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic
Lymphoma
5144
Poster
Monday, December 11, 6:00‑8:00
PM
A. Chanan‑Khan
Real-World Bruton Tyrosine Kinase
Inhibitor Treatment Patterns Among Patients with Chronic or Small
Lymphocytic Leukemia in US Community Oncology Practices
5163
Poster
Monday, December 11, 6:00‑8:00
PM
J.Z. Hou
Real-World Patterns of Care and
Financial Burden of Patients with Follicular Lymphoma in the United
States
5137
Poster
Monday, December 11, 6:00‑8:00
PM
B. Shah
Real-World Switching Pattern,
Persistence, and Associated Healthcare Resource Utilization of
Bruton Tyrosine Kinase Inhibitors for the Treatment of Mantle Cell
Lymphoma in the United States
5155
Poster
Monday, December 11, 6:00‑8:00
PM
B. Shah
Zanubrutinib vs FCR in fit
treatment-naive patients with chronic lymphocytic leukemia: A
matching-adjusted indirect comparison
6522
Online abstract
T. Munir
About BRUKINSA® (zanubrutinib) BRUKINSA is a small
molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to
deliver complete and sustained inhibition of the BTK protein by
optimizing bioavailability, half-life, and selectivity. With
differentiated pharmacokinetics compared with other approved BTK
inhibitors, BRUKINSA has been demonstrated to inhibit the
proliferation of malignant B cells within a number of
disease-relevant tissues.
About Sonrotoclax (BGB‑11417) Sonrotoclax is an
investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor.
It belongs to a class of BCL2 homology 3 (BH3) mimetics, and
preclinical and IND-enabling studies have demonstrated potent
activity and high selectivity of sonrotoclax against the
antiapoptotic protein BCL2. Sonrotoclax is more potent and
selective for BCL2 relative to BCLxL than venetoclax and shows the
potential to overcome common BCL2 resistance mutations.
About BGB‑16673 BGB‑16673 is an orally available Bruton’s
tyrosine kinase (BTK) targeting chimeric degradation activation
compound (CDAC) designed to induce degradation of wildtype and
multiple mutant forms of BTK, including those that commonly confer
resistance to BTK inhibitors in patients who experience progressive
disease.
About Tislelizumab Tislelizumab is a humanized
immunoglobulin G4 (IgG4) anti-programmed cell death protein 1
(PD‑1) monoclonal antibody with high affinity and binding
specificity against PD‑1. It is designed to minimize binding to
Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s
immune cells to detect and fight tumors.
U.S. Indications and Important Safety Information for
BRUKINSA (zanubrutinib)
INDICATIONS BRUKINSA is a kinase inhibitor indicated for
the treatment of adult patients with:
- Chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL)
- Waldenstr�m’s macroglobulinemia (WM)
- Mantle cell lymphoma (MCL) who have received at least one prior
therapy
- Relapsed or refractory marginal zone lymphoma (MZL) who have
received at least one anti-CD20-based regimen
The MCL and MZL indications are approved under accelerated
approval based on overall response rate. Continued approval for
these indications may be contingent upon verification and
description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Hemorrhage Fatal and serious hemorrhage has occurred in
patients with hematological malignancies treated with BRUKINSA
monotherapy. Grade 3 or higher hemorrhage, including intracranial
and gastrointestinal hemorrhage, hematuria and hemothorax have been
reported in 3.6% of patients treated with BRUKINSA monotherapy in
clinical trials, with fatalities occurring in 0.3% of patients.
Bleeding of any grade, excluding purpura and petechiae, occurred in
30% of patients.
Bleeding has occurred in patients with and without concomitant
antiplatelet or anticoagulation therapy. Coadministration 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 infections) and opportunistic
infections have occurred in patients with hematological
malignancies treated with BRUKINSA monotherapy. Grade 3 or higher
infections occurred in 24% of patients, most commonly pneumonia
(11%), with fatal infections occurring in 2.9% of patients.
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
(22%), thrombocytopenia (8%) and anemia (7%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 11% of patients, and
Grade 4 thrombocytopenia occurred in 2.8% 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 13% of patients
treated with BRUKINSA monotherapy. The most frequent second primary
malignancy was non-melanoma skin cancer reported in 7% of patients.
Other second primary malignancies included malignant solid tumors
(5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise
patients to use sun protection and monitor patients for the
development of second primary malignancies.
Cardiac Arrhythmias Serious cardiac arrhythmias have
occurred in patients treated with BRUKINSA. Atrial fibrillation and
atrial flutter were reported in 3.7% of 1550 patients treated with
BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of
patients. Patients with cardiac risk factors, hypertension and
acute infections may be at increased risk. Grade 3 or higher
ventricular arrhythmias were reported in 0.2% of patients.
Monitor for signs and symptoms of cardiac arrhythmias (e.g.
palpitations, dizziness, syncope, dyspnea, chest discomfort),
manage appropriately, and consider the risks and benefits of
continued BRUKINSA treatment.
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 In this pooled safety population, the
most common adverse reactions, including laboratory abnormalities,
in ≥30% of patients who received BRUKINSA (N=1550) included
decreased neutrophil count (42%), upper respiratory tract infection
(39%), decreased platelet count (34%), hemorrhage (30%), 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 strong or
moderate CYP3A inducers. Dose adjustment may be recommended with
moderate CYP3A inducers.
Specific Populations Hepatic Impairment: The
recommended dose of BRUKINSA for patients with severe hepatic
impairment is 80 mg orally twice daily.
Please see full U.S. Prescribing Information
including U.S. Patient Information.
About BeiGene BeiGene is a global biotechnology company
that is discovering and developing innovative oncology treatments
that are more affordable and accessible to cancer 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 10,000 colleagues spans five
continents, with administrative offices in Basel, Beijing, and
Cambridge, U.S. To learn more about BeiGene, please visit
www.beigene.com and follow us on LinkedIn and X (formerly known as
Twitter).
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 BeiGene’s ability
to advance promising treatment options for patients living with
blood cancers; future planned studies that may be conducted by
BeiGene; the future development, regulatory filing and approval and
commercialization of BRUKINSA, sonrotoclax and BGB-16673; and
BeiGene’s plans, commitments, aspirations, and goals under the
heading “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, commercialization, 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
of its drug candidates and achieve and maintain profitability; and
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.
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Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: Kyle Blankenship +1 667-351-5176
media@beigene.com
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