First presentation of SEQUOIA results reports
BRUKINSA’s superiority over chemoimmunotherapy in patients with
treatment-naïve chronic lymphocytic leukemia
Results from SEQUOIA in frontline CLL and the
positive ALPINE trial in the relapsed or refractory setting support
BRUKINSA’s potential to improve treatment outcomes for patients
with chronic lymphocytic leukemia
Additional data at ASH support BRUKINSA’s
therapeutic potential for patients intolerant to other BTK
inhibitor treatment
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide, today announced clinical results and real world
data from its hematology program to be presented at the 63rd
American Society of Hematology (ASH) Annual Meeting and Exposition,
including two oral presentations on the Phase 3 SEQUOIA trial
comparing BRUKINSA® (zanubrutinib) to bendamustine and rituximab
(B+R) in patients with treatment-naïve (TN) chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL). The ASH meeting
will take place on December 11-14, 2021, as a hybrid event in
Atlanta, GA and in a virtual format.
Jane Huang, M.D., Chief Medical Officer of Hematology at
BeiGene, commented: “Together with ALPINE, the positive SEQUOIA
trial provides evidence that BRUKINSA can improve treatment
outcomes for patients with CLL. Data at ASH this year reinforce our
belief that BRUKINSA’s differentiated design can bring patients
clinical benefits, including those who experience treatment
discontinuation with other BTK inhibitors. We look forward to
sharing more details on our clinical progress in our hematology
portfolio with the medical community in Atlanta.”
BRUKINSA Shows Promise in Improving CLL Treatment Outcomes
with Positive Results in SEQUOIA (vs. B+R) and ALPINE (vs.
Ibrutinib)
Following the positive ALPINE trial of BRUKINSA versus ibrutinib
in patients in the relapsed or refractory (R/R) setting in June
2021, BRUKINSA demonstrated superiority over B+R as a first-line
treatment for patients with CLL in SEQUOIA, the second positive
Phase 3 trial of BRUKINSA in CLL.
Data from the randomized Cohort 1 of SEQUOIA met the primary
endpoint at interim analysis, with BRUKINSA achieving a highly
statistically significant improvement in progression-free survival
(PFS) compared to B+R regimen. Efficacy results were consistent
between independent review committee (IRC) and investigator
assessments, with a hazard ratio (HR) of 0.42 for both, and were
observed across patient characteristics. The data also demonstrated
superiority in efficacy measured by overall response rate (ORR) as
assessed by both IRC and investigator. Similar to data observed in
its broad global clinical program, BRUKINSA was generally
well-tolerated in patients with CLL. In particular, low rates of a
key safety measurement—atrial fibrillation—were observed in the
SEQUOIA trial, consistent with data from ASPEN and ALPINE, the two
head-to-head Phase 3 trials of BRUKINSA versus ibrutinib.
In addition, early safety results from the ongoing Cohort 3 (Arm
D) evaluating BRUKINSA in combination with Bcl-2 inhibitor
venetoclax for CLL patients with del(17p), a high-risk
characteristic, suggested a good tolerability profile of the
combination.
Additional Data at ASH Support BRUKINSA’s Potential as an
Alternative for Patients Intolerant to Other BTK Inhibitors
To address tolerability issues commonly seen in other BTK
inhibitors, BRUKINSA was purposefully designed to optimize
selectivity to avoid off-target effects. In the ongoing Phase 2
trial BGB-3111-215 in patients with relapsed or refractory (R/R)
B-cell malignancies who were intolerant to prior treatment with
other approved BTK inhibitors, continued disease control or
improved responses were observed with BRUKINSA treatment. The
majority of patients (73%) on BRUKINSA did not experience
recurrence of adverse events that led to treatment discontinuation
with other BTK inhibitors.
BeiGene Presentations at the 63rd ASH Annual Meeting
Abstract Information
Date and Time
Presenting Author
Oral Presentations
#396: SEQUOIA: Results of a Phase 3
Randomized Study of Zanubrutinib versus Bendamustine + Rituximab
(BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic
Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
642. Chronic Lymphocytic Leukemia:
Clinical and Epidemiological I
Sun, Dec 12
10:45 AM ET
Constantine Tam
#67: Zanubrutinib in Combination with
Venetoclax for Patients with Treatment-Naïve (TN) Chronic
Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with
del(17p): Early Results from Arm D of the SEQUOIA (BGB-3111-304)
Trial
642. Chronic Lymphocytic Leukemia:
Clinical and Epidemiological I
Sat, Dec 11
10:45 AM ET
Alessandra Tedeschi
Poster or Mini Oral
Presentations
#1410: Phase 2 Study of Zanubrutinib in
BTK Inhibitor-Intolerant Patients (Pts) With Relapsed/Refractory
B-cell Malignancies
626. Aggressive Lymphomas: Prospective
Therapeutic Trials: Poster I
Sat, Dec 11
5:30 PM ET
Mazyar Shadman
#1419: Preliminary Safety and Efficacy
Data from Patients (Pts) With Relapsed/Refractory (R/R) B-cell
Malignancies Treated with the Novel B-cell Lymphoma 2 (BCL2)
Inhibitor BGB-11417 in Monotherapy or in Combination with
Zanubrutinib
626. Aggressive Lymphomas: Prospective
Therapeutic Trials: Poster I
Sat, Dec 11
5:30 PM ET
Constantine Tam
#3540: Preliminary Safety and Efficacy
from a Multicenter, Investigator-Initiated Phase II Study in
Untreated TP53 Mutant Mantle Cell Lymphoma with Zanubrutinib,
Obinutuzumab, and Venetoclax (BOVen)
623. Mantle Cell, Follicular, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
III
Mon, Dec 13
6:00 PM ET
Anita Kumar
#4078: Real-World Testing Patterns for Risk Assessment and
Implications on the Adoption of Novel Therapeutics in Chronic
Lymphocytic Leukemia: IGHV Mutation Status, FISH Cytogenetic, and
Immunophenotyping
905. Outcomes Research—Lymphoid
Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#3046: Real-World Bruton Tyrosine Kinase Inhibitor Treatment
Patterns, Compliance, Costs, and Hospitalizations in Patients with
Mantle Cell Lymphoma in the United States
905. Outcomes Research—Lymphoid
Malignancies: Poster II
Sun, Dec 12
6 PM ET
Bijal Shah
#4009: Productivity Loss and Indirect Costs Among Non-Hodgkin
Lymphoma Patients and Their Caregivers
902. Health Services Research—Lymphoid
Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#4077: Impact of Atrial Fibrillation on Cardiovascular and
Economic Outcomes in Patients with Chronic Lymphocytic Leukemia
905. Outcomes Research—Lymphoid
Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Anjana Mohan
#4079: Real-World Treatment Patterns, Adherence and Healthcare
Resource Utilization for Chronic Lymphocytic Leukemia/Small
Lymphocytic Leukemia Among Veterans in the United States
905. Outcomes Research—Lymphoid
Malignancies: Poster III
Mon, Dec 13
6:00 PM ET
Asher Chanan-Khan
#3048: Real-World Disease Burden, Costs and Resource Utilization
of Hospital-Based Care Among Mantle Cell Lymphoma, Waldenstr�m
Macroglobulinemia, Marginal Zone Lymphoma and Chronic Lymphocytic
Leukemia: Disparities and Risk Factors
905. Outcomes Research—Lymphoid
Malignancies: Poster II
Sun, Dec 12
6 PM ET
Asher Chanan-Khan
#1968: Factors Associated with Treatment Among Older Adults
Diagnosed with Chronic Lymphocytic Leukemia: An Analysis Using
Medicare Claims Data
905. Outcomes Research—Lymphoid
Malignancies: Poster I
Sat, Dec 11
5:30 PM ET
Eberechukwu Onukwugha
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. 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 approved in the following indications and
regions:
- For the treatment of mantle cell lymphoma (MCL) in adult
patients who have received at least one prior therapy (United
States, November 2019)*;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) in adult patients who have
received at least one prior therapy (China, June 2020)**;
- For the treatment of relapsed or refractory MCL (United Arab
Emirates, February 2021);
- For the treatment of Waldenstr�m’s macroglobulinemia (WM) in
adult patients (Canada, March 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States,
August 2021);
- For the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one anti-CD20-based regimen
(United States, September 2021)*;
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Singapore, October 2021);
- For the treatment of MCL in patients who have received at least
one prior therapy (Israel, October 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy, or in first line treatment for patients
unsuitable for chemo-immunotherapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received
at least one prior therapy (Australia, October 2021); and
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Russia, October 2021).
*
This indication was 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.
**
This indication was approved under
conditional approval. Complete approval for this indication may be
contingent upon results from ongoing randomized, controlled
confirmatory clinical trials.
To-date, more than 30 marketing authorization applications in
multiple indications have been submitted in the United States,
China, the European Union, and more than 20 other countries or
regions.
BeiGene Oncology
BeiGene is committed to advancing best and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D team of approximately 2,300
colleagues dedicated to advancing more than 90 clinical trials
involving more than 13,000 patients and healthy volunteers. Our
expansive portfolio is directed by a predominantly internalized
clinical development team supporting trials in more than 40
countries. Hematology-oncology and solid tumor targeted therapies
and immuno-oncology are key focus areas for the Company, with both
mono- and combination therapies prioritized in our research and
development. We currently market three medicines discovered and
developed in our labs: BTK inhibitor BRUKINSA in the United States,
China, Canada, Australia and additional international markets; and
non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and
PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen and Bristol Myers Squibb. We also plan to address greater
areas of unmet need globally through our collaborations including
with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen,
and Zymeworks. BeiGene has also entered into a collaboration with
Novartis granting Novartis rights to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,000 colleagues across five continents. 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
clinical benefits of BRUKINSA, BeiGene's plan for the advancement,
and anticipated clinical development, regulatory milestones and
commercialization of BRUKINSA, and BeiGene’s plans, commitments,
aspirations, and goals under the headings “BeiGene Oncology” 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 products 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 operating history and BeiGene's ability
to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; the
impact of the COVID-19 pandemic on the Company’s clinical
development, commercial 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/20211104005231/en/
BeiGene
Investor Contact Gabrielle Zhou +86 10-5895-8058 or +1
857-302-5189 ir@beigene.com
Media Contact Vivian Ni +1 857-302-7596
media@beigene.com
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