Study evaluating BRUKINSA® in combination with
venetoclax in high-risk, treatment-naïve CLL/SLL patients to be
shared as oral presentation
BCL2 inhibitor sonrotoclax subject of multiple
presentations highlighting promising safety and efficacy as
monotherapy and in combinations, including with backbone therapy
BRUKINSA
Phase 1/2 results for BTK degrader BGB-16673
showcasing encouraging efficacy and tolerability, including in BTK
inhibitor resistant disease
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced it will share new data from its
hematology portfolio and pipeline at the European Hematology
Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June
13-16, 2024. BeiGene has 28 abstracts accepted at EHA2024, with
four scheduled for oral presentations.
“As part of our dedication to bringing high-quality therapies to
patients around the world, our presentations at EHA2024 underscore
our continued commitment to expanding our hematology portfolio and
our efforts to build on the success of BRUKINSA’s unique clinical
profile across multiple B-cell malignancies,” said Mehrdad
Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at
BeiGene. “The data highlight the potential of our differentiated
investigational BCL2 inhibitor, sonrotoclax, as a monotherapy and
in combination regimens, and the promise of BTK degradation to
address the unmet needs of patients facing certain blood
cancers.”
New Data Expand Evidence Base for BRUKINSA
(zanubrutinib)
- Oral presentation of new data from an arm of the SEQUOIA study
in patients with high-risk treatment-naïve (TN) chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL) with del(17p)
and/or TP53 mutation treated with BRUKINSA and venetoclax,
demonstrating strong efficacy and favorable safety (Abstract
S160)
- Oral presentation sharing the results of an adverse event (AE)
based economic analysis comparing BRUKINSA with acalabrutinib; in
terms of AE management, BRUKINSA was cost-saving and associated
with quality of life benefits compared to acalabrutinib (Abstract
S333)
- Presentation of a post hoc analysis evaluating the risk of
developing hypertension among ALPINE trial participants with
relapsed or refractory (R/R) CLL/SLL, which demonstrated patients
in the ibrutinib arm initiated new and/or a new class of
anti-hypertensive medications more frequently than patients in the
BRUKINSA arm (Abstract P1836)
- Results of an intra-patient comparative analysis from ROSEWOOD
study of BRUKINSA plus obinutuzumab in patients with R/R follicular
lymphoma (FL), supporting the efficacy benefit of the combination
in this patient population (Abstract P1143)
- Multiple additional presentations featuring patient-reported
outcomes and real-world differentiation of BRUKINSA among BTK
inhibitors
Emerging Data Demonstrate Hematology Pipeline
Strengths
- Oral presentation of a Phase 1 study of BeiGene’s novel BCL2
inhibitor sonrotoclax (BGB-11417) in combination with BRUKINSA,
demonstrating deep and durable responses with a tolerable safety
profile in patients with R/R CLL/SLL; the combination of
sonrotoclax with backbone therapy BRUKINSA is being evaluated in
the randomized Phase 3 CELESTIAL study (NCT06073821) in patients
with TN CLL (Abstract S156)
- Poster presentation of Phase 1a/1b open-label dose escalation
and expansion study of sonrotoclax in combination with BRUKINSA in
R/R mantle cell lymphoma (MCL), showing the combination was
generally well tolerated and demonstrated promising efficacy,
including high rate of deep and durable responses (Abstract
P1112)
- Additional presentations highlighting Phase 1 results for
sonrotoclax, demonstrating encouraging response rates, durable
responses and manageable safety profiles spanning multiple
indications across B-cell and myeloid malignancies, including:
- As monotherapy in R/R Waldenstr�m's macroglobulinemia (Abstract
P1110)
- In combination with azacitidine in both TN and R/R acute
myeloid leukemia (Abstracts P538 and P562)
- In combination with dexamethasone in R/R multiple myeloma
harboring t(11;14) (Abstract P898)
- Oral presentation of data from the ongoing, first-in-human
Phase 1/2 study of BeiGene’s Bruton tyrosine kinase (BTK) degrader
BGB-16673, highlighting tolerable safety and promising efficacy in
heavily pretreated patients with R/R CLL/SLL (NCT05006716);
BGB-16673, which induces BTK degradation, is the first
investigational drug from BeiGene’s chimeric degradation activation
compound (CDAC) platform (Abstract S157)
- Additional data from the Phase 1/2 study of BTK CDAC BGB-16673,
demonstrating a tolerable safety profile and preliminary efficacy
in heavily pretreated patients with different types of non-Hodgkin
lymphoma, including those with BTKi-resistant disease (Abstract
P1119)
BeiGene Presentations During EHA2024
Abstract Title
Abstract #
Presentation Type
Presenting Author
BTK CDAC (investigational
compound)
Preliminary efficacy and safety of the
Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with
relapsed or refractory (R/R) CLL/SLL: Results from the phase 1
BGB-16673-101 study
S157
Oral
R. Parrondo
Preliminary efficacy and safety of the
Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with
relapsed or refractory (R/R) indolent NHL: Results from the phase 1
BGB-16673-101 study
P1119
Poster
C. Cheah
Sonrotoclax (investigational
compound)
Results from the phase 1 study of the
novel BCL2 inhibitor sonrotoclax (sonro) in combination with
zanubrutinib (zanu) for relapsed/refractory (R/R) CLL/SLL show deep
and durable responses
S156
Oral
S. Opat
Combination treatment with novel BCL-2
inhibitor sonrotoclax (BGB-11417) and zanubrutinib induces high
rate of complete remission for patients with relapsed/refractory
(R/R) mantle cell lymphoma (MCL)
P1112
Poster
C. Tam
Safety and efficacy results of a phase 1
study of the novel BCL2 inhibitor sonrotoclax (BGB-11417) for
relapsed/refractory Waldenstr�m's macroglobulinemia
P1110
Poster
C Cheah
Preliminary safety and antileukemic
activity of sonrotoclax (BGB-11417), a potent and selective BCL2
inhibitor, in treatment-naive patients with acute myeloid
leukemia
P538
Poster
S. Tan
Preliminary safety and antileukemic
activity of sonrotoclax (BGB-11417), a potent and selective BCL2
inhibitor, in patients with relapsed/refractory acute myeloid
leukemia
P562
Poster
P. Montesinos
Sonrotoclax plus dexamethasone is
tolerable and demonstrates antimyeloma activity in patients with
relapsed/refractory (R/R) multiple myeloma harboring t(11;14)
P898
Poster
B. Dhakal
BGB-11417-203, an ongoing, phase 2 study
of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in
patients with Waldenstr�m macroglobulinemia
PB2954
Online abstract
J. Matous
CELESTIAL-TN CLL: An ongoing, open-label,
multiregional, phase 3 study of sonrotoclax (BGB-11417) +
zanubrutinib vs venetoclax + obinutuzumab for treatment-naive (TN)
CLL
PB2540
Online abstract
P. Patten
Zanubrutinib
Combination of zanubrutinib + venetoclax
for treatment-naive (TN) CLL/SLL with del(17p) and/or TP53:
Preliminary results from SEQUOIA arm D
S160
Oral
P. Ghia
Intra-patient comparative analysis of
zanubrutinib plus obinutuzumab efficacy in relapsed/refractory
follicular lymphoma using the Growth Modulation Index
P1143
Poster
K. Bouabdallah
Risk of hypertension in patients with
CLL/SLL who participated in ALPINE: A post hoc analysis
P1836
ePoster
W. White
Risk of new-onset hypertension in newly
diagnosed chronic lymphocytic leukemia patients treated with Bruton
tyrosine kinase inhibitors: A real-world study using the Symphony
Health Solutions database
P1847
ePoster
W. White
Zanubrutinib vs. acalabrutinib in B-cell
malignancies: an adverse event-based economic analysis
S333
Oral
T. Munir
Efficacy of zanubrutinib versus
acalabrutinib in the treatment of relapsed or refractory chronic
lymphocytic leukemia (R/R CLL): A matching-adjusted indirect
comparison (MAIC)
P700
Poster
M. Shadman
Efficacy and safety of zanubrutinib vs.
venetoclax+ibrutinib in the treatment-naïve (TN) chronic
lymphocytic leukemia (CLL): A matching-adjusted indirect comparison
(MAIC)
P702
Poster
T. Munir
Matching-adjusted indirect comparison
(MAIC) of zanubrutinib versus real-world chemoimmunotherapy (CIT)
or chemotherapy (chemo) in relapsed/refractory marginal zone
lymphoma (R/R MZL)
P1123
Poster
R. Walewska
Indirect comparison of efficacy of
zanubrutinib versus acalabrutinib in the treatment of
relapsed/refractory mantle cell lymphoma
P2058
ePoster
B. Shah
Comparative efficacy of Bruton tyrosine
kinase inhibitors in the treatment of relapsed/refractory chronic
lymphocytic leukemia: A network meta-analysis
P701
Poster
M. Shadman
Zanubrutinib vs other Bruton’s tyrosine
kinase inhibitors in relapsed/refractory chronic lymphocytic
leukemia: A multilevel network meta-regression
P698
Poster
M. Shadman
Patient-reported outcome (PRO)–based
recurrent symptomatic deterioration predicts disease progression:
Results from the ALPINE trial
P1834
ePoster
J. Brown
Real-world comparative effectiveness of
covalent Bruton tyrosine kinase inhibitors (cBTKi) among patients
with relapsed/refractory mantle cell lymphoma (R/R MCL)
P1139
Poster
T. Phillips
Real-world treatment switching and
sequencing to next line of therapy of zanubrutinib, acalabrutinib,
and ibrutinib in CLL/SLL
P697
Poster
J. Pinilla-Ibarz
Real-world Bruton tyrosine kinase
inhibitor treatment patterns and outcomes among patients with
chronic lymphocytic leukemia or small lymphocytic lymphoma
(CLL/SLL) in US community oncology practices
P685
Poster
J. Hou
Real-world evaluation of treatment
pattern, time to next treatment, healthcare resource utilization,
and cost of care in follicular lymphoma
P1124
Poster
S. Gaballa
Real-world adherence and healthcare
resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in
mantle cell lymphoma
P2045
ePoster
B. Shah
Recent patterns of care with BTK
inhibitors and distribution of social determinants of health among
patients with CLL/SLL in the US community setting
PB2546
Online abstract
D. Andorsky
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.
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.
- Relapsed or refractory follicular lymphoma (FL), in combination
with obinutuzumab, after two or more lines of systemic
therapy.
The MCL, MZL and FL indications are approved under accelerated
approval based on overall response rate and durability of response.
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. Grade 3 or higher
hemorrhage including intracranial and gastrointestinal hemorrhage,
hematuria, and hemothorax was reported in 3.8% of patients treated
with BRUKINSA in clinical trials, with fatalities occurring in 0.2%
of patients. Bleeding of any grade, excluding purpura and
petechiae, occurred in 32% 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 before and after
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.
Grade 3 or higher infections occurred in 26% of patients, most
commonly pneumonia (7.9%), with fatal infections occurring in 3.2%
of patients. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jirovecii 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 (21%),
thrombocytopenia (8%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA. Grade 4
neutropenia occurred in 10% of patients, and Grade 4
thrombocytopenia occurred in 2.5% 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. The most
frequent second primary malignancy was non-melanoma skin cancers
(8%), followed by other solid tumors in 7% of the patients
(including melanoma in 1% of patients) and hematologic malignancies
(0.7%). 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 4.4% patients treated with BRUKINSA, including Grade 3 or higher
cases in 1.9% 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 0.3% 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
The most common adverse reactions (≥30%), including laboratory
abnormalities, in patients who received BRUKINSA (N=1729) are
decreased neutrophil count (51%), decreased platelet count (41%),
upper respiratory tract infection (38%), hemorrhage (32%), and
musculoskeletal pain (31%).
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.
This information is intended for a global audience. Product
indications vary by region.
About BeiGene
BeiGene is a global oncology company that is discovering and
developing innovative 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. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), and Facebook.
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 continued commitment to expanding its hematology
portfolio; the promise of BTK degradation to address unmet needs of
blood cancer patients; 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; BeiGene’s 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.
To access BeiGene media resources, please visit our News
& Media site.
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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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