Trial met primary endpoint of non-inferior
overall survival versus sorafenib
Results mark eighth positive Phase 3 trial
readout for tislelizumab across multiple cancer types and lines of
therapy
Data to be submitted for presentation at
upcoming medical conference
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company focused on developing innovative and
affordable oncology medicines to improve treatment outcomes and
access for patients worldwide, today announced that the global
Phase 3 RATIONALE 301 trial with tislelizumab met its primary
endpoint of non-inferior Overall Survival (OS) versus sorafenib as
a first-line treatment in adult patients with unresectable
hepatocellular carcinoma (HCC). The safety profile for tislelizumab
was consistent with previous studies and no new safety signals were
reported. More than 600 patients in the U.S., Europe, and Asia
participated in the study.
HCC is the sixth most common type of cancer worldwide,
accounting for more than 900,000 new cases in 2020i, and despite
improvements in screening, surveillance rules, and imaging, more
than two-thirds of patients with HCC present with advanced disease
at diagnosisii.
“Patients with unresectable HCC face a devastating prognosis,
with a median life expectancy of one year. Currently there are few
treatment options if patients cannot tolerate TKI therapy or if
their condition progresses,” said Mark Lanasa M.D., Ph.D., Chief
Medical Officer, Solid Tumors at BeiGene. “We are encouraged by the
outcome of the final analysis of RATIONALE 301 and look forward to
sharing the full safety and efficacy results at an upcoming medical
conference.”
RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized,
open-label study of tislelizumab compared with sorafenib as a
first-line treatment in adult patients with unresectable HCC. The
primary endpoint of the study is non-inferiority of OS between the
two treatment groups. The key secondary endpoint is Overall
Response Rate, as assessed by Blinded Independent Review Committee
(BIRC) per RECIST v1.1. Other secondary endpoints include other
efficacy assessments such as Progression-Free Survival, Durability
of Response, and Time to Progression per BIRC, as well as measures
of health-related quality of life, and safety and tolerability.
About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody
specifically designed to minimize binding to Fc-gamma (Fcγ)
receptors on macrophages, helping to aid the body’s immune cells to
detect and fight tumors. In pre-clinical studies, binding to Fcγ
receptors on macrophages has been shown to compromise the
anti-tumor activity of PD-1 antibodies through activation of
antibody-dependent macrophage-mediated killing of T effector
cells.
Tislelizumab is the first drug from BeiGene’s immuno-oncology
biologics program and is being developed internationally as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers.
The global tislelizumab clinical development program includes
more than 11,000 subjects enrolled to-date in 30 countries and
regions. BeiGene has initiated or completed 22
registration-enabling clinical trials. More information on the
clinical trial program for tislelizumab can be found here.
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 and medical affairs team of
approximately 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 subjects. Our
expansive portfolio is directed predominantly by our internal
colleagues supporting clinical trials in more than 45 countries and
regions. 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. BeiGene currently has three approved medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Great Britain, 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, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor, ociperlimab, that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
Oncology products across designated regions of China.
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 8,500 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 for tislelizumab to treat patients with unresectable
HCC, plans for development of tislelizumab in HCC, BeiGene's
advancement of anticipated clinical development, regulatory
milestones and commercialization of tislelizumab, 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 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 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.
i GLOBOCAN 2020 ii Kim DY , Han KH . Epidemiology and
surveillance of hepatocellular carcinoma. Liver Cancer 1(1), 2–14
(2012)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809005409/en/
Investors: Kevin Mannix +1 240-410-0129
ir@beigene.com
Media: Kathleen Cuca +1 551 222 6790
media@beigene.com
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Jun 2024 to Jul 2024
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Jul 2023 to Jul 2024