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, presented preliminary clinical data from
Chinese patients with microsatellite instability-high (MSI-H) or
mismatch repair-deficient (dMMR) solid tumors enrolled in an
ongoing Phase 1/2 clinical trial of tislelizumab, an
investigational anti-PD-1 antibody, at the 21st Annual Meeting of
the Chinese Society of Clinical Oncology (CSCO) in Xiamen, China.
“Tislelizumab is being developed in a broad
clinical program as both a monotherapy and in combination with
other treatments for a number of potential clinical indications. We
are encouraged by the preliminary results presented today with
tislelizumab for patients with MSI-H or dMMR solid tumors and are
excited about starting a Phase 2 trial in China in patients with
advanced forms of these tumors to test our belief that they are
sensitive to immune checkpoint inhibition. We hope this further
enables the availability of new treatments options, which are
urgently needed, especially in China,” commented Amy Peterson,
M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene.
“This is the first presentation of tislelizumab
data in the population of patients with MSI-H or dMMR solid tumors,
and we are encouraged by the objective response rate of 29 percent
in a difficult-to-treat patient population. Tislelizumab was also
generally well-tolerated in these patients,” said Lin Shen, M.D.,
Vice President of Clinical Oncology at Beijing Cancer Hospital and
Peking University, and study presenter. “We hope that further study
of tislelizumab may lead to a new treatment for patients with these
tumors.”
Summary of Results from the MSI-H and dMMR
Cohorts in the Phase 1/2 Trial
The multi-center, open-label Phase 1/2 trial of
tislelizumab as monotherapy in advanced solid tumors in China
(CTR20160872) consists of a Phase 1 dose verification component and
a Phase 2 component of indication expansion in disease-specific
cohorts, which includes MSI-H and dMMR solid tumors.
Data presented at CSCO today are from 22 patients
enrolled in the cohort, of which 14 patients with centrally
confirmed MSI-H/dMMR tumors were evaluable for antitumor activity
per RECIST v1.1 criteria. Patients were treated with tislelizumab
at a dose of 200 mg every three weeks. Colorectal cancer was the
most common primary tumor type and 82 percent of the study
population received one or more prior lines of systemic therapy. At
the time of the data cutoff on May 11, 2018, median treatment
duration was 2.2 months (0.69-11.1 months), median follow-up time
was 4.4 months (0.10-10.7 months), and ten patients remained on
treatment.
Adverse events (AEs) assessed by the investigator
to be related to treatment occurred in 18 patients (82%). Of those,
the most common treatment-related AEs (TRAEs) (occurring in ≥ 15%
of patients) were increased bilirubin (36%), increased transaminase
(27%), increased blood creatine phosphokinase (23%), anemia (23%)
and decreased white blood cell and/or neutrophil count (18%). All
of the TRAEs were grades 1 or 2. Immune-related AEs (irAEs)
occurred in 13 patients (59%) and many were overlapping with the
TRAE cases. All irAEs were grade 1 or 2 as well.
At the time of the data cutoff, the efficacy
evaluation was early and 14 patients, including 12 patients with
colorectal cancer, with centrally confirmed MSI-H/dMMR tumors were
evaluable for response. The objective response rate was 29 percent
(four patients, all with colorectal cancer), with the median
duration of response still maturing. Additionally, three patients
centrally confirmed as negative for MSI-H/dMMR were evaluable for
response, and progressive disease was the best response in all
three of these patients.
In addition to this Phase 1/2 trial, tislelizumab
is being investigated in two pivotal Phase 2 clinical trials in
China in relapsed/refractory (R/R) classical Hodgkin’s lymphoma and
in urothelial cancer, Phase 3 trials in China and globally in a
number of malignancies including non-small cell lung cancer,
hepatocellular carcinoma, and esophageal squamous cell carcinoma;
as well as two global Phase 2 trials in patients with previously
treated hepatocellular carcinoma or with R/R mature T- and NK-cell
lymphomas.
About Microsatellite Instability-High or Mismatch Repair
Deficient Solid TumorsMicrosatellite instability-high
(MSI-H) cancer cells have a greater than normal number of genetic
markers called microsatellites, which are short, repeated sequences
of DNA. Cancer cells that have large numbers of microsatellites may
have defects in the ability to correct mistakes (also known as
mismatch repair deficiency, or dMMR) that occur when DNA is copied
in the cell. MSI-H and dMMR tumors are found most often in
colorectal cancer, other types of gastrointestinal cancer and
endometrial cancer, although they may also be found in cancers of
the breast, prostate, bladder and thyroid.
About TislelizumabTislelizumab
(BGB-A317) is an investigational humanized monoclonal antibody that
belongs to a class of immuno-oncology agents known as immune
checkpoint inhibitors. Discovered by BeiGene scientists in Beijing,
tislelizumab is designed to bind to PD-1, a cell surface receptor
that plays an important role in downregulating the immune system by
preventing the activation of T-cells. Tislelizumab has demonstrated
high affinity and specificity for PD-1. It is potentially
differentiated from the currently approved PD-1 antibodies in an
engineered Fc region, which is believed to minimize potentially
negative interactions with other immune cells, based on preclinical
data. Tislelizumab 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. BeiGene and Celgene
Corporation have a global strategic collaboration for the
development of tislelizumab in solid tumor cancers outside of Asia
(except Japan).
About BeiGeneBeiGene is a global,
commercial-stage, research-based biotechnology company focused on
molecularly-targeted and immuno-oncology cancer therapeutics. With
a team of over 1,300 employees in China, the United States,
Australia and Switzerland, 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. BeiGene markets ABRAXANE® (nanoparticle albumin–bound
paclitaxel), REVLIMID® (lenalidomide) and VIDAZA® (azacitidine) in
China under a license from Celgene Corporation.i
Forward-Looking StatementsThis 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 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 ContactCraig
West
Liza Heapes+1
857-302-5189
+1 857-302-5663ir@beigene.com
media@beigene.com
i ABRAXANE®, REVLIMID® and VIDAZA® are
registered trademarks of Celgene Corporation.
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