BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage
biopharmaceutical company focused on developing and commercializing
innovative molecularly-targeted and immuno-oncology drugs for the
treatment of cancer, today announced that the pivotal Phase 3 trial
evaluating its anti-PD-1 antibody tislelizumab in combination with
two chemotherapy regimens for the first-line treatment of patients
with squamous non-small cell lung cancer (NSCLC), met the primary
endpoint of improved progression-free survival (PFS) at the planned
interim analysis, as assessed by independent review committee
(IRC). In this study, patients with previously untreated advanced
squamous NSCLC were randomized to receive either tislelizumab in
combination with paclitaxel and carboplatin, tislelizumab in
combination with nanoparticle albumin-bound (nab) paclitaxel
(ABRAXANE®) and carboplatin, or paclitaxel and carboplatin alone.
Based on the pre-planned interim analysis, both tislelizumab
treatment arms crossed the pre-specified efficacy boundary compared
to chemotherapy alone. The safety profile of tislelizumab in both
combinations in this trial was consistent with the known risks of
each study treatment, and no new safety signals were identified.
“Tislelizumab was recently approved in China for patients with
relapsed or refractory classical Hodgkin’s lymphoma, and we have a
broad development program with more than 5,000 patients enrolled in
over 25 tislelizumab studies, including 15 potentially
registration-enabling trials,” commented Yong (Ben) Ben, M.D.,
Chief Medical Officer, Immuno-Oncology at BeiGene. “We are
extremely excited about the compelling results that tislelizumab
demonstrated in this Phase 3 trial and for its potential use as a
first-line treatment for patients in China with advanced squamous
NSCLC. We look forward to continuing the development program for
tislelizumab in lung cancer, which includes three other Phase 3
trials, and reporting additional data.”
The company plans to discuss its plans for filing a supplemental
new drug application (sNDA) for tislelizumab as a first-line
treatment for squamous NSCLC with the Center for Drug Evaluation
(CDE) at the National Medical Products Administration (NMPA) in
China and to present these data at an upcoming medical meeting.
This trial (NCT 03594747, known as BGB-A317-307) is a Phase 3,
randomized, open-label, multi-center trial investigating
tislelizumab combined with either paclitaxel and carboplatin or
nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in
China) and carboplatin compared with paclitaxel and carboplatin
alone in patients with untreated stage IIIB or IV squamous NSCLC
from mainland China, regardless of PD-L1 expression. The primary
endpoint is PFS per IRC. Key secondary endpoints include overall
survival and safety. The study began enrolling patients in July
2018, and 360 patients were randomized 1:1:1 to receive
tislelizumab (200mg every three weeks) in combination with each of
the chemotherapy regimens or chemotherapy only, until disease
progression, unacceptable toxicity, physician decision or consent
withdrawal. Patients on the chemotherapy-only control arm who
experienced disease progression, verified by central independent
review, were eligible to cross over to receive tislelizumab
monotherapy.
“Squamous NSCLC remains a significant unmet need, representing
approximately 30 percent of patients with NSCLC in China. This
Phase 3 study was designed to assess the impact of tislelizumab
given in combination with chemotherapy as a potential treatment to
improve outcomes in patients with advanced squamous NSCLC, for whom
prognoses are typically quite poor. These results give us hope that
we could have a new treatment option for these patients,” commented
Jie Wang, M.D., Professor at the Cancer Hospital Chinese Academy of
Medical Sciences, in Beijing, China and lead investigator for the
trial.
About Non-Small Cell Lung Cancer
In contrast to most Western countries where lung cancer death
rates are decreasing, lung cancer incidence rate is still
increasing in China.1,[2] There were approximately 770,000 new
cases of lung cancer in China in 2018 and it is the leading cause
of cancer-related death in both men and women, with approximately
690,500 deaths in China in 2018.3 Non-small cell lung cancer
(NSCLC) comprises the most common form of lung cancer in
China.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 as a monotherapy and in combination with other
therapies for the treatment of a broad array of both solid tumor
and hematologic cancers.
Tislelizumab is approved by the China National Medical Products
Administration (NMPA) as a treatment for patients with classical
Hodgkin’s lymphoma who received at least two prior therapies. A
supplemental new drug application (sNDA) for tislelizumab in
patients with previously treated locally advanced or metastatic
urothelial carcinoma has been granted priority review by the Center
for Drug Evaluation at the NMPA and is currently under review.
Tislelizumab is being studied in a broad clinical program as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers. Currently, 15 potentially registration-enabling clinical
trials are being conducted in China and globally, including 11
Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China.
About BeiGene
BeiGene is a global, commercial-stage research-based
biotechnology company focused on molecularly-targeted and
immuno-oncology cancer therapeutics. With a team of over 3,400
employees in the United States, China, Australia, and Europe,
BeiGene is advancing a pipeline consisting of novel oral small
molecules and monoclonal antibodies for cancer. BeiGene is also
working to create combination solutions aimed to have both a
meaningful and lasting impact on cancer patients. In the United
States, BeiGene markets and distributes BRUKINSA™ (zanubrutinib)
and in China, the Company has received approval to market its
anti-PD-1 antibody tislelizumab and markets ABRAXANE® (nanoparticle
albumin-bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA®
(azacitidine) under a license from Celgene Logistics Sarl, a
Bristol-Myers Squibb company,5 and plans to market XGEVA®
(denosumab) under a license from Amgen.6 For more information
please visit www.beigene.com.
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 BGB-A317-307 Phase 3 trial of tislelizumab in
patients with previously untreated advanced squamous NSCLC and
other clinical trials of tislelizumab, the potential implications
of clinical data for patients, BeiGene’s plans to discuss data from
the BGB-A317-307 trial with the NMPA and present the data at an
upcoming medical meeting, and BeiGene's advancement of, and
anticipated clinical development, regulatory milestones and
commercialization of tislelizumab. 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 technology and
drugs; 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, 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.
Investor Contact |
Media
Contact |
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Craig West |
Liza Heapes |
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+1 857-302-5189 |
+ 1 857-302-5663 |
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ir@beigene.com |
media@beigene.com |
1 Jemal A, Bray F, Center MM, et al. Global cancer statistics.
CA Cancer J Clin 2011;61:69-90.
2 She J, Yang P, Hong Q, et al. Lung cancer in China: challenges
and interventions. Chest 2013;143:1117-26.
3 Feng et al. Cancer Communications (2019) 39:22
https://doi.org/10.1186/s40880-019-0368-6
4 Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and
survivorship statistics, 2012. CA Cancer J Clin 2012;62:220-41.
5 ABRAXANE® is a registered trademark of Abraxis Bioscience LLC,
a Bristol-Myers Squibb company; REVLIMID® and VIDAZA® are
registered trademarks of Celgene Corporation, a Bristol-Myers
Squibb company
6 XGEVA® is a registered trademark of Amgen
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