EU approval follows recent approvals for
BRUKINSA including U.S., China, Brazil, and Canada
The approval is based on Phase 3 ASPEN
head-to-head trial comparing BRUKINSA against ibrutinib
BeiGene (NASDAQ: BGNE; HKEX: 06160) announced today that the
European Commission (EC) approved BRUKINSA® (zanubrutinib) for the
treatment of adult patients with Waldenstr�m’s macroglobulinemia
(WM) who have received at least one prior therapy or for the
first-line treatment of patients unsuitable for
chemo-immunotherapy. The approval is applicable to all 27 European
Union (EU) member states, plus Iceland and Norway. BeiGene is
working to make this new treatment option available to WM patients
in the EU as quickly as possible.
“BTK inhibition is an established mode of treatment for patients
with WM, and the approval of BRUKINSA provides an important new
option for patients with WM that may offer improved outcomes,” said
Prof. Christian Buske, Medical Director at the University Hospital
Ulm, Germany, and a trial investigator of the ASPEN study.
“Patients and their physicians in the EU will soon have access to
an innovative medicine that has potential to offer deep and durable
responses and improved tolerability, as seen in the ASPEN
trial.”
The EC approval for BRUKINSA follows a positive opinion granted
in September by the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA), based on the results
of the ASPEN trial. Although the primary endpoint of statistical
superiority related to deep response, very good partial response
(VGPR) or better, was not met, BRUKINSA demonstrated clinical
benefit with advantages in safety compared to ibrutinib.1 Read more
about the positive CHMP opinion and ASPEN trial results here.
“With BRUKINSA now approved in the EU, we continue to execute on
our commitment of making this potentially best-in-class BTK
inhibitor available for more patients around the world who may
benefit,” said Jane Huang, M.D., Chief Medical Officer, Haematology
at BeiGene. “BRUKINSA was designed to maximize BTK occupancy and
minimize off-target effects and has demonstrated efficacy and
advantages in safety and tolerability over ibrutinib in the ASPEN
trial. We believe BRUKINSA will become the preferred treatment
option among patients with WM and their physicians.”
“We have built a strong team in Europe that is committed to
creating access to BRUKINSA for patients living with WM,” said
Gerwin Winter, Senior Vice President, Head of Commercial, Europe at
BeiGene. “This approval by the European Commission is a significant
milestone for BeiGene’s expansion in the region, representing
another step towards BeiGene’s goal of increasing access to
innovative oncology medicines globally.”
About Waldenstr�m’s Macroglobulinemia
Waldenstr�m’s macroglobulinemia (WM) is a generally indolent and
relatively rare B-cell malignancy characterized by bone marrow
infiltration with monoclonal immunoglobulin M (IgM) secreting
lymphoplasmacytic cells. WM represents approximately one percent of
all non-Hodgkin’s lymphomas and typically progresses slowly after
diagnosis.2 The disease usually affects older adults and is
primarily found in the bone marrow, although lymph nodes and the
spleen may be involved.3 Throughout Europe, the estimated incidence
rate of WM is approximately seven out of every one million men and
four out of every one million women.4
About the ASPEN trial
The Phase 3 randomized, open-label, multicentre ASPEN clinical
trial (NCT03053440) evaluated BRUKINSA (zanubrutinib) versus
ibrutinib in patients with relapsed or refractory (R/R) WM or
treatment-naïve (TN) WM considered unsuitable for treatment with
chemoimmunotherapy. The primary objective was to establish
superiority of BRUKINSA compared to ibrutinib as demonstrated by
the proportion of patients achieving complete response or very good
partial response. Secondary endpoints included major response rate
(MRR), duration of response (DoR) and progression-free survival
(PFS), and safety, measured by incidence, timing and severity of
treatment-emergent adverse events. The pre-specified analysis
populations for the trial included the overall population (n=201),
of which the majority were R/R patients (n=164). Exploratory
endpoints included quality of life measures.
As assessed by an independent review committee (IRC) based on
the modified Sixth International Workshop on Waldenstr�m’s
Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the
combined rate of complete response (CR) and VGPR in the overall
intention-to-treat (ITT) population was 28% with BRUKINSA (95% CI:
20, 38), compared to 19% with ibrutinib (95% CI: 12, 28). While
this difference was not statistically significant, BRUKINSA did
achieve numerically higher VGPR rates and trends towards increased
response quality.1
In the ASPEN trial, BRUKINSA demonstrated a more favorable
safety profile compared to ibrutinib with lower frequency of
adverse reactions that have raised concern with BTK inhibitors,
including atrial fibrillation or flutter (2% vs. 15%), minor
bleeding (49% vs. 59%) and major hemorrhage (6% vs. 9%). Despite
higher rates of grade ≥3 neutropenia, patients on BRUKINSA did not
demonstrate higher rates of infection as compared to those
receiving ibrutinib. Of the 101 patients with WM treated with
BRUKINSA, 4% of patients discontinued due to adverse events, and
adverse events leading to dose reduction occurred in 14% of
patients.1
The study includes three arms in two cohorts, a randomized
cohort (Cohort 1, N=201) consisting of patients with a MYD88
mutation (MYD88MUT) and a non-randomized cohort (Cohort 2, N=28) in
which patients with MYD88 wild-type (MYD88WT) received BRUKINSA
because historic data indicated they were unlikely to benefit from
ibrutinib. The randomized Cohort 1 enrolled 102 patients (including
83 R/R patients and 19 TN patients) in the BRUKINSA arm and 99
patients (including 81 R/R patients and 18 TN patients) in the
ibrutinib arm. Patients in the BRUKINSA arm were assigned to
receive BRUKINSA 160 mg twice daily (BID) and patients in the
ibrutinib arm received 420 mg of ibrutinib once daily (QD).
About BRUKINSA
BRUKINSA (zanubrutinib) 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 now approved in the United States, China, the
European Union and nine other countries and regions. To date, more
than 20 marketing authorization applications have been submitted
for BRUKINSA for various indications.
Safety Information
The most commonly occurring adverse reactions (≥20%) were
neutropenia (56.2%), thrombocytopenia (45.1%), upper respiratory
tract infection (44.3%), hemorrhage/hematoma (32.2%), rash (29.8%),
bruising (29.1%), anemia (28.9%), musculoskeletal pain (24.3%),
diarrhea (23.6%), pneumonia (22.1%) and cough (21.7%).
The most common Grade 3 or higher adverse reactions (>5%)
were neutropenia (28.0%), pneumonia (11.6%), thrombocytopenia
(11.4%), and anemia (6.9%).
Of the 779 patients treated with zanubrutinib, 3.6% of patients
discontinued treatment due to adverse reactions. The most frequent
adverse reaction leading to treatment discontinuation was pneumonia
(1.8%). Adverse reaction leading to dose reduction occurred in 4.9%
of patients.
The recommended total daily dose of zanubrutinib is 320 mg. The
daily dose may be taken either once daily (four 80 mg capsules) or
divided into two doses of 160 mg twice daily (two 80 mg
capsules).
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 2,750
colleagues dedicated to advancing more than 90 ongoing or planned
clinical trials involving more than 14,000 patients and healthy
volunteers. Our expansive portfolio is directed predominantly by
our internal colleagues supporting clinical trials in more than 45
countries and regions. Haematology-oncology and solid tumour
targeted therapies and immuno-oncology are key focus areas for the
Company, with both mono- and combination therapies prioritized in
our research and development. BeiGene currently has three approved
medicines discovered and developed in our own labs: BTK inhibitor
BRUKINSA in the United States, China, the EU, Canada, Australia,
and additional international markets; and the non-FC-gamma receptor
binding anti-PD-1 antibody tislelizumab as well as the 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 7,700 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
the planned commercialization and market access of BRUKINSA in the
European Union and additional development, regulatory filings and
potential approvals in other markets, the potential for BRUKINSA to
be a best-in-class BTK inhibitor, the potential for BRUKINSA to
provide improved clinical benefits with advantages in safety, the
potential for BRUKINSA to become the preferred treatment option
among patients with WM and their physicians, the potential
commercial opportunity for 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.
* 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)a;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (China, June 2020) b;
- For the treatment of chronic lymphocytic leukaemia (CLL) or
small lymphocytic lymphoma (SLL) in adult patients who have
received at least one prior therapy (China, June 2020) b;
- 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)b;
- 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);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Russia, October 2021);
- For the treatment of mantle cell lymphoma (MCL) in adult
patients who have received at least one prior therapy (Saudi
Arabia, November 2021); and
- For the treatment of adult patients for the treatment of adult
patients with WM who have received at least one prior therapy or
first-line treatment of patients unsuitable for chemo-immunotherapy
(European Union, November 2021).
a. 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.
b. This indication was approved under
conditional approval. Complete approval for this indication may be
contingent upon results from ongoing randomized, controlled
confirmatory clinical trials.
References:
1. Tam, et al. A randomized phase 3 trial of zanubrutinib vs
ibrutinib in symptomatic Waldenstr�m macroglobulinemia: the ASPEN
study. Blood. October 2020. 136(18): 2038-2050.
2. Lymphoma Research Foundation. Getting the Facts: Waldenstr�m
Macroglobulinemia. Available at
https://lymphoma.org/wp-content/uploads/2020/09/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf.
Updated 2020.
3. Lymphoma Research Foundation. Available at
https://lymphoma.org/aboutlymphoma/nhl/wm/. Accessed December
2020.
4. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211123006162/en/
BeiGene Investor Gabrielle Zhou +86 10-5895-8058
or +1 857-302-5189 ir@beigene.com
Media Emily Collins +1 201-201-4570 media@beigene.com
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