Studies of BRUKINSA® (zanubrutinib), BTK CDAC
degrader BGB-16673 and BCL2 inhibitor sonrotoclax featured in
invited talks and oral presentations
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced it will share research from
studies evaluating BRUKINSA® (zanubrutinib), Bruton tyrosine kinase
(BTK) chimeric degradation activation compound (CDAC) degrader
BGB-16673 and B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in
patients with Waldenstr�m’s macroglobulinemia at the 12th
International Workshop on Waldenstr�m's Macroglobulinemia (IWWM)
Oct. 17-19 in Prague, Czech Republic.
BeiGene has seven presentations at IWWM 2024, and Mehrdad
Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at
BeiGene, will give the opening ceremony keynote, “Innovating for
Impact: How BeiGene is Advancing Products and Pipeline to Address
Waldenstrom’s Macroglobulinemia and Beyond.”
“Waldenstr�m’s macroglobulinemia is a rare and incurable cancer,
and many patients face treatment failure after initial lines of
therapy,” Dr. Mobasher said. “Our BTK inhibitor BRUKINSA has become
a standard of care for these patients and as shown through our
long-term follow-up data at IWWM, continues to demonstrate deep and
durable responses with favorable safety. Additional presentations
demonstrate our continued commitment to developing and evaluating
new treatment options for Waldenstr�m’s macroglobulinemia patients
and include results from Phase 1 studies of our BTK CDAC degrader
BGB-16673 and BCL2 inhibitor sonrotoclax. We are encouraged by
these results and look forward to advancing these assets to help
more patients with WM.”
During IWWM, BeiGene research will be shared in two invited
talks, three oral presentations and two posters. Key presentations
are outlined below.
IWWM Session Title &
Timing (CEST)
Session Type
Asset
Key Findings
BTK-Inhibitors in WM I
(Oct. 18, 11:30 a.m.-12:30
p.m.)
Oral presentation
BRUKINSA
Long-term safety and efficacy data from
ASPEN LTE1, a long-term extension study evaluating
ibrutinib-treated patients from ASPEN who switched to BRUKINSA,
show that worsening of ibrutinib treatment-emergent AEs following
transition to BRUKINSA was rare, as was the emergence of new
events. The study also finds that efficacy is also maintained or
improved in these patients.
BTK-I Intolerant and Resistant
Disease
(Oct. 18, 2:30-3:30 p.m.)
Invited talk
BGB-16673
Preliminary safety and efficacy data from
the phase 1 CaDAnCe-101 study demonstrates that BGB-16673 has a
tolerable safety profile and shows promising antitumor activity in
heavily pretreated patients with BTK inhibitor-exposed
relapsed/refractory (R/R) WM, including those with BTK and CXCR4
mutations. BGB-16673 was recently granted Fast Track Designation by
the U.S. Food and Drug Administration for R/R chronic lymphocytic
leukemia or small lymphocytic lymphoma (CLL/SLL).
Invited talk
BRUKINSA
Updated results from a Phase 2 study of WM
patients who switched to BRUKINSA after becoming intolerant to
other BTK inhibitors, including ibrutinib and acalabrutinib, show
that most adverse events (AEs) that led to intolerance did not
recur after treatment with BRUKINSA. Additionally, efficacy was
maintained or improved in these patients.
WM Poster Presentations &
Reception
(Oct. 18, 4:30-6:30 p.m.)
Poster
BRUKINSA
An analysis of the Phase 3 ASPEN study
demonstrates that peripheral neuropathy (PN) symptom resolution
with BTK inhibitors correlates with depth of disease response, with
faster symptom resolution with BRUKINSA than ibrutinib in patients
achieving PN resolution.
Poster
N/A
Results of a UK-wide patient-centered
experience survey demonstrate that active monitoring for
asymptomatic patients with WM is highly variable, with more than
half of participants stating their experience could be
improved.
Plenary Session II
(Oct. 19, 9-10 a.m.)
Oral Presentation
Sonrotoclax
Results from the Phase 1 study show that
sonrotoclax was generally well tolerated and the preliminary
antitumor activity is encouraging in patients with heavily
pretreated R/R WM.
Clinical Trials in Progress for
WM II
(Oct. 19, 4-5 p.m.)
Oral presentation
Sonrotoclax
Trial-in-progress presentation provides an
overview of a Phase 2 study of sonrotoclax in patients with R/R WM,
who have been previously treated with a BTK inhibitor therapy or
anti-CD20–based systemic therapy.
About Waldenstr�m’s Macroglobulinemia (WM)
Waldenstr�m’s macroglobulinemia (WM) is a rare B-cell lymphoma
that occurs in less than 2% of patients with non-Hodgkin
lymphomas.1 The disease usually affects older adults and is
primarily found in bone marrow, although lymph nodes and the spleen
may be involved.2 Typically, patients present between the ages of
60 and 70 years. For reasons that are unclear, WM is almost twice
as common in men as in women and is more common in Caucasians than
other ethnic groups.3 WM is a rare cancer seen only in
approximately three to five per million people per year.2
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.
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.
Hepatotoxicity, Including Drug-Induced Liver Injury
Hepatotoxicity, including severe, life-threatening, and
potentially fatal cases of drug-induced liver injury (DILI), has
occurred in patients treated with Bruton tyrosine kinase
inhibitors, including BRUKINSA.
Evaluate bilirubin and transaminases at baseline and throughout
treatment with BRUKINSA. For patients who develop abnormal liver
tests after BRUKINSA, monitor more frequently for liver test
abnormalities and clinical signs and symptoms of hepatic toxicity.
If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI,
discontinue BRUKINSA.
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), Facebook and Instagram.
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
BRUKINSA’s ability to provide deep and durable responses with
favorable safety for WM patients; BeiGene’s ability to further
advance its BTK CDAC degrader BGB-16673 and BCL2 inhibitor
sonrotoclax; 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.
1 Buske, C, et al. Treatment and outcome
patterns in European patients with Waldenstr�m’s
macroglobulinaemia: a large, observational, retrospective chart
review. The Lancet Haematology 2018; 5: e0299-309.
2 Lymphoma Research Foundation. Getting
the Facts: Waldenstr�m Macroglobulinemia. Accessed March 2022.
Available at
https://lymphoma.org/wp-content/uploads/2021/12/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf
3 IWMF. Frequently Asked Questions –
Waldenstrom’s Macroglobulinemia.
https://iwmf.com/frequently-asked-questions-waldenstrom-macroglobulinemia/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241016421498/en/
Media: Kim Bencker +1 610-256-8932 media@beigene.com
To access BeiGene media resources, please visit our News
& Media site.
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Oct 2024 to Nov 2024
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Nov 2023 to Nov 2024
