BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today announced that the Center for
Drug Evaluation (CDE) of the China National Medical Products
Administration (NMPA) has accepted a supplemental Biologics License
Application (sBLA) for anti-PD-1 antibody tislelizumab in
combination with chemotherapy as a first-line treatment for
patients with recurrent or metastatic nasopharyngeal cancer
(NPC).
“Treatment options for NPC, one of the most common head and neck
cancers in China and many parts of Asia, are limited, with
chemotherapy continuing to dominate front-line care. Supported by
the positive RATIONALE 309 trial, the NMPA acceptance of this sBLA,
which is the ninth for tislelizumab in China, represents an
incredible milestone in its development history and serves as a
validation of this potentially differentiated checkpoint
inhibitor,” commented Yong (Ben) Ben, M.D., Chief Medical Officer,
Immuno-Oncology at BeiGene. “We look forward to bringing this
important immunotherapy to the underserved NPC patient community in
China.”
The sBLA is supported by clinical results from a randomized,
double-blind, Phase 3 clinical trial RATIONALE 309 (NCT03924986) to
evaluate the efficacy and safety of tislelizumab combined with
gemcitabine and cisplatin versus placebo combined with gemcitabine
and cisplatin as a first-line treatment for patients with recurrent
or metastatic NPC. The primary endpoint of this trial is
progression-free survival (PFS) as assessed by independent review
committee (IRC) in the intention-to-treat (ITT) population;
secondary endpoints include overall survival (OS), IRC-assessed
overall response rate (ORR) and duration of response (DoR), and
investigator-assessed PFS. A total of 263 Asian patients were
enrolled and randomized 1:1 to either the tislelizumab plus
chemotherapy arm or the placebo plus chemotherapy arm.
As announced in May 2021, RATIONALE 309 met the primary endpoint
of PFS at the planned interim analysis. The safety profile of
tislelizumab was consistent with its known risks, with no new
safety signals identified with the addition of chemotherapy.
BeiGene expects to present results from the RATIONALE 309 trial at
an upcoming medical conference.
About Nasopharyngeal Cancer (NPC)
Nasopharyngeal cancer (NPC) is a malignant, squamous cell
carcinoma which arises from the epithelial cells of the
nasopharynx, most commonly originating in the pharyngeal recess
(the fossa of Rosenmüller).i There were an estimated 62,555 new
cases of NPC in China in 2020, accounting for 46.8 percent of the
worldwide incidence.ii Despite the heavy public health burden of
NPC in southern China and other endemic areas, relatively little is
known about the etiology and prevention of NPC.iii The major risk
factors for NPC are genetic predisposition, Epstein-Barr virus
(EBV) infection, and consumption of salt-preserved food.iv The
median overall survival rate is about 20 months in advanced NPC;v
however, progressively worsening prognoses falling to a three-year
survival of 7-40% were reported in patients with recurrent or
metastatic NPC, indicating a high medical unmet need for more
effective treatment.vi,vii,viii
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to FcγR on
macrophages. In pre-clinical studies, binding to FcγR 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 China National Medical Products Administration (NMPA) has
granted tislelizumab approval in five indications, including full
approval for first-line treatment of patients with advanced
squamous non-small cell lung cancer (NSCLC) in combination with
chemotherapy and for first-line treatment of patients with advanced
non-squamous NSCLC in combination with chemotherapy; and
conditional approval for the treatment of patients with classical
Hodgkin’s lymphoma (cHL) who received at least two prior therapies,
for the treatment of patients with locally advanced or metastatic
urothelial carcinoma (UC) with PD-L1 high expression whose disease
progressed during or following platinum-containing chemotherapy or
within 12 months of neoadjuvant or adjuvant treatment with
platinum-containing chemotherapy, and for the treatment of patients
with hepatocellular carcinoma (HCC) who have received at least one
systemic therapy. Full approval for these indications is contingent
upon results from ongoing randomized, controlled confirmatory
clinical trials.
In addition, four supplemental Biologics License Applications
for tislelizumab have been accepted by the Center for Drug
Evaluation (CDE) of the NMPA and are under review for second- or
third-line treatment of patients with locally advanced or
metastatic NSCLC who progressed on prior platinum-based
chemotherapy, for patients with previously treated, locally
advanced unresectable or metastatic microsatellite instability-high
(MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the
treatment of patients with locally advanced or metastatic
esophageal squamous cell carcinoma (ESCC) who have disease
progression following or are intolerant to first-line standard
chemotherapy, and for first-line treatment of patients with
recurrent or metastatic nasopharyngeal cancer (NPC).
BeiGene has initiated or completed 17 potentially
registration-enabling clinical trials in China and globally,
including 13 Phase 3 trials and four pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a
collaboration and license agreement granting Novartis rights to
develop, manufacture, and commercialize tislelizumab in North
America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.
About the Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- Phase 3 trial comparing
tislelizumab with docetaxel in the second- or third-line setting in
patients with NSCLC (NCT03358875);
- Phase 3 trial comparing
tislelizumab to salvage chemotherapy in patients with relapsed or
refractory classical Hodgkin Lymphoma (cHL;
NCT04486391);
- Phase 3 trial in patients
with locally advanced or metastatic urothelial carcinoma
(NCT03967977);
- Phase 3 trial of tislelizumab
in combination with chemotherapy versus chemotherapy as first-line
treatment for patients with advanced squamous NSCLC
(NCT03594747);
- Phase 3 trial of tislelizumab
in combination with chemotherapy versus chemotherapy as first-line
treatment for patients with advanced non-squamous NSCLC
(NCT03663205);
- Phase 3 trial of tislelizumab
in combination with platinum-based doublet chemotherapy as
neoadjuvant treatment for patients with NSCLC
(NCT04379635);
- Phase 3 trial of tislelizumab
combined with platinum and etoposide versus placebo combined with
platinum and etoposide in patients with extensive-stage small cell
lung cancer (NCT04005716);
- Phase 3 trial comparing
tislelizumab with sorafenib as first-line treatment for patients
with hepatocellular carcinoma (HCC; NCT03412773);
- Phase 2 trial in patients
with previously treated unresectable HCC (NCT03419897);
- Phase 2 trial in patients
with locally advanced or metastatic urothelial bladder cancer
(NCT04004221);
- Phase 3 trial comparing
tislelizumab with chemotherapy as second-line treatment for
patients with advanced esophageal squamous cell carcinoma (ESCC;
NCT03430843);
- Phase 3 trial of tislelizumab
in combination with chemotherapy as first-line treatment for
patients with ESCC (NCT03783442);
- Phase 3 trial of tislelizumab
versus placebo in combination with chemoradiotherapy in patients
with localized ESCC (NCT03957590);
- Phase 3 trial of tislelizumab
combined with chemotherapy versus placebo combined with
chemotherapy as first-line treatment for patients with gastric
cancer (NCT03777657);
- Phase 2 trial of tislelizumab
in patients with relapsed or refractory cHL
(NCT03209973);
- Phase 2 trial in patients
with MSI-H/dMMR solid tumors (NCT03736889); and
- Phase 3 trial of tislelizumab
combined with chemotherapy versus placebo combined with
chemotherapy as first-line treatment in patients with
nasopharyngeal cancer (NCT03924986).
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 to 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. The Company currently
markets three medicines discovered and developed in our labs: BTK
inhibitor BRUKINSA in the United States, China, Canada, 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 approximately 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
data from the RATIONALE 309 trial, the filing and potential
approval of an sBLA in China based on the data, plans to present
the data, the potential clinical benefits to patients, BeiGene's
plan for the advancement, and 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
and commercialization of its drug candidates and achieve and
maintain profitability; the impact of the COVID-19 pandemic on the
BeiGene’s clinical development, regulatory, 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.
i Yu, M. C., & Yuan, J.-M. (2002). Epidemiology of
nasopharyngeal carcinoma. Seminars in Cancer Biology, 12(6),
421–429. https://doi.org/10.1016/s1044579x02000858. ii Globocan
2020. Available at
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Access July 2021. iii Wu, L., Li, C., & Pan, L. (2018).
Nasopharyngeal carcinoma: A review of current updates. Experimental
and Therapeutic Medicine, 15(4), 3687–3692.
https://doi.org/10.3892/etm.2018.5878. iv Liu, Y.-T., Dai, J.-J.,
Xu, C.-H., Lu, Y.-K., Fan, Y.-Y., Zhang, X.-L., Zhang, C.-X., &
Chen, Y.-M. (2012). Greater intake of fruit and vegetables is
associated with lower risk of nasopharyngeal carcinoma in Chinese
adults: A case-control study. Cancer Causes & Control: CCC,
23(4), 589–599. https://doi.org/10.1007/s10552-012-9923-z. v Perri,
F., (2019). Management of recurrent nasopharyngeal carcinoma:
current perspectives. Onco Targets Ther, 12, 1583-1591.
doi:10.2147/OTT.S188148. vi Li, J.-X., Huang, S.-M., Wen, B.-X.,
& Lu, T.-X. (2014). Prognostic factors on overall survival of
newly diagnosed metastatic nasopharyngeal carcinoma. Asian Pacific
Journal of Cancer Prevention: APJCP, 15(7), 3169–3173.
https://doi.org/10.7314/apjcp.2014.15.7.3169 vii Toumi, N.,
Ennouri, S., Charfeddine, I., Daoud, J., & Khanfir, A. (2020).
Prognostic factors in metastatic nasopharyngeal carcinoma.
Brazilian Journal of Otorhinolaryngology.
https://doi.org/10.1016/j.bjorl.2020.05.022 viii Xu, Y., Huang, T.,
Mao, M., Zhai, J., & Chen, J. (2020). Metastatic Patterns and
Prognosis of de novo Metastatic Nasopharyngeal Carcinoma in the
United States. The Laryngoscope.
https://doi.org/10.1002/lary.28983
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Investor Contact Gabrielle Zhou +86 10-5895-8058 or +1
857-302-5189 ir@beigene.com
Media Contact Liza Heapes or Vivian Ni +1 857-302-5663 or
+1 857-302-7596 media@beigene.com
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