- New follow-up results from Phase 3 SEQUOIA
trial and post hoc safety analyses for BRUKINSA® (zanubrutinib)
reinforce potential across various B-cell malignancies
- Early results for BTK-targeted CDAC
(BGB-16673) and BCL-2 inhibitor (BGB-11417) in various B-cell
malignancies illustrate promise of pipeline
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced the presentation of new data
from its broad blood cancer portfolio of approved therapies and
promising early-stage pipeline products at the 2023 European
Hematology Association (EHA) Hybrid Congress. BeiGene has ten
accepted abstracts at EHA, which is taking place from June 8-11 in
Frankfurt, Germany.
“We are excited to share the latest research from our robust
hematology portfolio and pipeline, including new results that
further deepen our understanding of BRUKINSA across a number of
hematologic malignancies,” said Lai Wang, Ph.D., Global Head of
R&D at BeiGene. “These data underscore our ongoing commitment
to delivering treatments that have the potential to improve the
lives of those living with blood cancers.”
Expanding the Evidence Base for BRUKINSA
With extended follow-up from the pivotal, Phase 3 SEQUOIA study,
BRUKINSA remains an important frontline treatment option for
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL). BRUKINSA continued to demonstrate clinically meaningful
efficacy in patients with treatment-naïve CLL/SLL without del(17p).
In addition to the previously reported benefit in patients with the
unmutated immunoglobulin heavy chain (IGHV) gene, longer follow-up
now shows benefit in those with mutated IGHV as well, and patients
with del(17p) continue to demonstrate progression-free survival
(PFS) benefit consistent with the randomized cohort. BRUKINSA
continues to be well tolerated over time, with low rates of
treatment discontinuation. (Abstract #P639)
In post-hoc analyses, safety data were pooled from ten clinical
trials of BRUKINSA monotherapy in patients with certain B-cell
malignancies, including from the Phase 3 ASPEN and ALPINE trials,
which compared BRUKINSA head-to-head with ibrutinib. These pooled
safety analyses demonstrate that BRUKINSA is generally well
tolerated, as BRUKINSA adverse events were generally
mild-to-moderate in severity and tended not to lead to treatment
discontinuation. Prevalence of adverse events of special interest
(AESI) generally trended down over time without emergence of new
safety signals, supporting BRUKINSA as a viable long-term treatment
option. (Abstract #P631)
In an updated safety and efficacy analysis of BRUKINSA in
patients with various B-cell malignancies, results showed that
switching to BRUKINSA may provide clinical benefit to patients
previously intolerant of ibrutinib and/or acalabrutinib. In total,
82 patients were evaluated (61 CLL/SLL, 13 Waldenstr�m’s
macroglobulinemia, 4 mantle cell lymphoma, 4 marginal zone
lymphoma). (Abstract #P633)
Additionally, in an updated analysis of the Phase 2 ROSEWOOD
study, BRUKINSA plus obinutuzumab, a humanized type II anti-CD20
monoclonal antibody, demonstrated clinically meaningful activity
and manageable safety profile in patients with heavily pretreated
relapsed/refractory (R/R) follicular lymphoma (FL). The European
Medicines Agency recently validated BeiGene’s Type II variation
application for BRUKINSA for the treatment of adult patients with
R/R FL. (Abstract #P1080)
BeiGene’s Promising Early Pipeline in Hematology
BGB-16673 is an orally available Bruton’s tyrosine kinase
(BTK)-targeting chimeric degradation activation compound (CDAC)
that is designed to be a potent inhibitor against tumors expressing
wildtype and clinically relevant BTK mutations. The investigative
molecule is currently being evaluated in Phase 1 trials
(NCT05006716, NCT05294731). The preclinical findings presented at
EHA suggest BGB-16673 is a promising next-generation BTK inhibitor
that could benefit patients who developed BTKi on-target resistant
mutations. (Abstract #P1219)
Additionally, in an encore presentation from the American
Society of Clinical Oncology Annual Meeting, BGB-11417, a potent
and highly selective BCL-2 inhibitor, showed promising initial
efficacy results in relapsed/refractory CLL/SLL, with patients
achieving responses at lower dose levels. (Abstract #P626)
About BRUKINSA® (zanubrutinib) BRUKINSA is a small
molecule inhibitor of 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. Because new BTK is continuously
synthesized, BRUKINSA was specifically designed to deliver complete
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 4,900 subjects in 35 trials across 29 markets. To date,
BRUKINSA is approved in more than 65 markets around the world,
including the United States, China, the European Union, Great
Britain, Canada, Australia, South Korea, and Switzerland.
About BGB-16673 BGB 16673 is an orally available BTK
targeting CDAC designed to degrade wildtype BTK and multiple mutant
forms. It is currently under phase 1 clinical investigations
(NCT05006716, NCT05294731).
About BGB-11417 BGB-11417 is an investigational small
molecule BCL-2 inhibitor. Preclinical and IND-enabling studies of
BGB-11417 have demonstrated potent activity and high selectivity
against the pro-apoptotic protein BCL-2. The molecule is more
selective than venetoclax for BCL-2 relative to BCL-xL and shows
the potential to overcome resistance to venetoclax.
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 9,400 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.
U.S. IMPORTANT SAFETY INFORMATION FOR
BRUKINSA (zanubrutinib)
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 for 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, 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
Lactation: Advise not to breastfeed.
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
INDICATIONS
- BRUKINSA is 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.
Please see full U.S. Prescribing Information including
U.S. Patient Information.
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 strength of
BeiGene’s blood cancer portfolio and pipeline; the potential for
BeiGeneto deliver treatments that have the potential to improve the
lives of those living with blood cancers; the potential for
BRUKINSA to be an important frontline treatment option for CLL or
SLL; the general future of BeiGene’s pipeline and programs;
BeiGene’s advancement, anticipated clinical development, regulatory
milestones and commercialization of BGB-11417, BGB-16673, and
zanubrutinib; 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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230609005039/en/
Investor Contact: Kevin Mannix +1 240-410-0129
ir@beigene.com Media Contact: Maryline Iva + 41 61 685 2090
media@beigene.com
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