Final ALPINE Progression-Free Survival
(PFS) results simultaneously published in The New England Journal
of Medicine and presented at late-breaking session at 64th American
Society of Hematology Annual Meeting
BRUKINSA demonstrated superiority to IMBRUVICA
in both PFS and Overall Response Rate with fewer cardiac events
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) a global
biotechnology company, today presented the final progression-free
survival (PFS) analysis of the ALPINE trial demonstrating superior
efficacy and a favorable cardiac safety profile for patients
receiving BRUKINSA® as compared to IMBRUVICA® in a
global phase 3 trial in patients with relapsed/refractory (R/R)
chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia
(SLL). These data will be presented (Abstract #LBA-6) during the
late-breaking session at the 64th American Society of Hematology
(ASH) Annual Meeting in New Orleans and simultaneously published in
The New England Journal of Medicine. The paper’s lead author
Jennifer Brown, M.D., Ph.D., Director, CLL Center at Dana-Farber
Cancer Institute will present these data.
Dr. Brown noted that “PFS is the gold standard for measuring
efficacy in CLL clinical trials. The ALPINE data showing superior
efficacy and consistent benefit across patient subgroups including
patients with high-risk del(17p)/TP53, along with a favorable
cardiovascular safety profile, provide compelling evidence for
BRUKINSA as a practice-changing Bruton’s tyrosine kinase (BTK)
inhibitor for patients with CLL.”
“BRUKINSA was specifically designed to maximize BTK occupancy
and minimize off-target effects. Our clinical development programs
were intended to test for a differentiated efficacy and safety
profile,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical
Officer, Hematology at BeiGene. “We believe the ALPINE PFS data and
cardiac safety results for BRUKINSA, including an absence of
cardiac death, demonstrate a meaningful advance in outcomes for
patients with CLL.”
In this final analysis, BRUKINSA achieved superior PFS over
ibrutinib (HR: 0.65 [95% CI, 0.49-0.86] p=0.0024, for both
Independent Review Committee [IRC] and investigator). At 24 months,
the investigator-assessed PFS rates were 78.4% for BRUKINSA
compared to 65.9% with ibrutinib. The PFS benefit was observed
across all major subgroups, including high-risk del(17p)/TP53 (HR:
0.52; [95% CI, 0.30-0.88]), as assessed by IRC. BRUKINSA also
demonstrated higher overall response rate (ORR), with a response
rate of 80.4% versus 72.9% (two-sided p=0.0264), as assessed by
IRC.
BRUKINSA was generally well-tolerated with fewer adverse events
leading to treatment discontinuation compared with ibrutinib (15.4%
vs. 22.2%). There was a lower rate of cardiac disorders for
BRUKINSA compared with ibrutinib (21.3% vs 29.6%), and cardiac
disorders leading to treatment discontinuation occurred in one
BRUKINSA patient versus 14 ibrutinib patients (0.3% vs. 4.3%). No
patient receiving BRUKINSA died due to a cardiac adverse event; six
patients receiving ibrutinib experienced a fatal cardiac adverse
event (0% vs. 1.9%). The most commonly reported treatment emergent
adverse events (≥20%) with BRUKINSA and ibrutinib were diarrhea
(16.0% vs. 24.1%), hypertension (14.8% vs. 11.1%), neutropenia
(22.8% vs. 18.2%), COVID-19 (23.1% vs. 17.9%), and upper
respiratory tract infection (21.0% vs. 14.2%).
CLL is the most common type of leukemia in adults, accounting
for about one-quarter of new cases of leukemia in the United
States.1 The condition is characterized by consecutive relapses,
with response to therapy ultimately determining clinical benefit,
including survival.
BeiGene’s sNDA for BRUKINSA in CLL is currently under review
with the FDA and has a target action date of January 20, 2023.
Investor Events
- Tuesday, December 13, 2022 - BeiGene will host a webcast
and conference call following the ALPINE late-breaker presentation
at 2:00 p.m. CST. BeiGene senior management along with invited
medical experts will review the presented data and join for a
Q&A panel.
- Dial in: 855-303-0072; Passcode: 306575
- Tuesday, December 13, 2022 - BeiGene will host a webcast
in Chinese at 6:00 p.m. CST/December 14, 2022 8:00 a.m. China time
to capture company presentations at ASH. BeiGene senior management
will review highlights of the presented data.
- Dial in: +86 10 8783 3177 or +86 10 5387 6330; Passcode:
03233799
These events can be accessed live from the Investors section of
BeiGene’s website at http://ir.beigene.com,
http://hkexir.beigene.com or https://sseir.beigene.com. Archived
replays will be posted for 90 days following both events.
About ALPINE
ALPINE is a randomized, global Phase 3 trial (NCT03734016)
comparing BRUKINSA against ibrutinib in previously treated patients
with relapsed or refractory chronic lymphocytic leukemia CLL or
SLL. In the trial, a total of 652 patients across Europe (60%), the
United States (17%), China (14%), New Zealand and Australia (9%)
were randomized into two arms, with the first receiving BRUKINSA
(160 mg orally twice daily) and the second receiving ibrutinib (420
mg orally once daily) until disease progression or unacceptable
toxicity.
The primary endpoint of overall response rate (ORR), defined by
pre-specified non-inferiority of BRUKINSA versus ibrutinib, was
assessed by investigator and IRC using the modified 2008 iwCLL
guidelines, with modification for treatment-related lymphocytosis
for patients with CLL, and per Lugano Classification for
non-Hodgkin’s lymphoma for patients with SLL. There was
pre-specified hierarchical testing of non-inferiority followed by
superiority in ORR as assessed by investigator and IRC. Key
secondary endpoints include PFS and event rate of atrial
fibrillation or flutter; other secondary endpoints include duration
of response, overall survival, and incidence of adverse events.
Interim study results from ALPINE were published online in
Journal of Clinical Oncology in November 2022 (DOI:
10.1200/JCO.22.00510).
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. BRUKINSA was specifically designed to
deliver targeted 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 4,700 subjects in 35 trials in more than 30 geographies.
To date, BRUKINSA is approved in more than 60 markets, including
the United States, China, the European Union, Great Britain,
Canada, Australia, South Korea, Switzerland, and additional
international markets.
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more 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 9,000 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.
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 potential implications of the Phase 3 ALPINE trial data for
patients, the timing of regulatory review and potential approval of
BRUKINSA as a new treatment option for patients with CLL, the
potential for BRUKINSA to provide clinical benefit to patients with
CLL, 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 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.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC and
Janssen Biotech, Inc.
References
[1] National Cancer Institute. Surveillance, Epidemiology, and
End Results Program. Cancer Stat Facts: Leukemia —Chronic
Lymphocytic Leukemia (CLL). Accessed October 4, 2021.
https://seer.cancer.gov/statfacts/html/clyl.html
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version on businesswire.com: https://www.businesswire.com/news/home/20221213005484/en/
Investors Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Kyle Blankenship +1 667 3515176 media@beigene.com
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