This marks the first ex-China regulatory filing
for tislelizumab, following approval in five indications in
China
The accepted BLA, filed in collaboration with
Novartis, is supported by the positive global Phase 3 RATIONALE 302
trial in patients with previously treated, advanced or metastatic
ESCC and safety data from tislelizumab’s broad clinical program
With its second internally developed medicine
filed outside China, BeiGene furthers its commitment to expanding
access to innovative treatments for cancer patients worldwide
BeiGene, Ltd. (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 that the U.S.
Food and Drug Administration (FDA) accepted for review a Biologics
License Application (BLA) for its anti-PD-1 antibody tislelizumab
as a treatment for patients with unresectable recurrent locally
advanced or metastatic esophageal squamous cell carcinoma (ESCC)
after prior systemic therapy. The Prescription Drug User Fee Act
(PDUFA) target action date is July 12, 2022.
“Our uniquely designed anti-PD-1 antibody tislelizumab has been
shown to significantly improve survival compared to chemotherapy
for people with a variety of solid tumors and hematologic
malignancies. We previously shared the compelling results at ASCO
2021 with tislelizumab significantly prolonging survival and
demonstrating a favorable safety profile over chemotherapy in
patients with locally advanced or metastatic ESCC, a devastating
disease with an average five-year survival rate of just five
percent. This BLA acceptance brings us closer to potentially
providing tislelizumab as a treatment for these patients in the
United States,” said Yong (Ben) Ben, M.D., Chief Medical Officer,
Immuno-Oncology at BeiGene. “Tislelizumab is already approved in
five indications in China and has the potential to become a
preferred immunotherapy option there. We look forward to continued
collaboration with Novartis to work to bring access to tislelizumab
to patients around the world.”
The BLA submission is based on results from RATIONALE 302, a
randomized, open-label, multicenter global Phase 3 trial
(NCT03430843) designed to evaluate the efficacy and safety of
tislelizumab when compared to investigator’s choice chemotherapy as
a second-line treatment for patients with advanced or metastatic
ESCC. Results of this trial were presented at the 2021 American
Society of Clinical Oncology Annual Meeting (ASCO 2021). The
submission also included safety data on 1,972 patients who received
tislelizumab as a monotherapy from seven clinical trials.
In addition to the United States, tislelizumab is also under
regulatory review in China as a treatment for patients with locally
advanced or metastatic ESCC who have disease progression following
or are intolerant to first-line standard chemotherapy.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is one of the most common malignant tumors in
the digestive tract, with more than 18,400 new cases diagnosed each
year in the United States.1 There are two main types of esophageal
cancer, based on the cells where cancer develop: squamous cell
carcinoma (ESCC) and adenocarcinoma (EAC).2 ESCC accounts for up to
30% of esophageal cancer cases in the United States, and is the
most common form of esophageal cancer worldwide.2,3,4 Because many
patients are diagnosed at later stages of disease, management of
ESCC is challenging and the overall prognosis remains poor.3,4
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
approved tislelizumab 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. NMPA also granted
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, three supplemental Biologics License Applications
for tislelizumab are under review by the Center for Drug Evaluation
(CDE) of the NMPA, including as 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 and 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.
In the U.S., a Biologics License Application for tislelizumab as
a treatment for patients with unresectable recurrent locally
advanced or metastatic ESCC after prior systemic therapy is
currently under review by the U.S. Food and Drug Administration
with a PDUFA target action date of July 12, 2022.
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 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, 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
the filing and potential approval of a BLA for tislelizumab in ESCC
in the United States, plans for development and commercialization
of tislelizumab in the United States, China and other markets,
plans for making tislelizumab accessible to patients in the United
States and other markets, the potential for tislelizumab to provide
improved clinical benefit to patients, 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.
References:
- Siegel RL et al. CA Cancer J Clin 2020 Jan;70(1):7-30
- American Cancer Society. What is Esophageal Cancer? Available
at
https://www.cancer.org/cancer/esophagus-cancer/about/what-is-cancer-of-the-esophagus.html
Accessed August 2021.
- Codipilly DC et al. Gastrointest Endosc. 2018 Sep; 88(3):
413–426.
- Abnet CC et al. Gastroenterology. 2018 Jan; 154(2):
360–373.
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version on businesswire.com: https://www.businesswire.com/news/home/20210912005031/en/
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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