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 clinical data on tislelizumab, an
investigational anti-PD-1 antibody, in Chinese patients with lung
cancers, in two oral presentations at the 21st Annual Meeting of
the Chinese Society of Clinical Oncology (CSCO) in Xiamen, China.
“Advanced lung cancer is one of our focus areas for
development of tislelizumab, where we hope to have an impact on the
way patients are treated both in China and worldwide. This complex
and difficult-to-treat disease has proven to be susceptible to
treatment with immunotherapies,” commented Amy Peterson, M.D.,
Chief Medical Officer, Immuno-Oncology, at BeiGene. “The
preliminary data presented today demonstrate that tislelizumab is
generally well tolerated and has antitumor activity both as
monotherapy and in combination with several chemotherapy regimens
used in small cell and non-small cell lung cancer patients. We are
hopeful that further study of tislelizumab may lead to a new
treatment option for a broad array of patients with lung
cancers.”
Summary of Preliminary Results of Phase 2
Trial in China of Tislelizumab Combined with Chemotherapy as
First-Line Treatment in Advanced Lung Cancer Setting
The multi-center, open-label Phase 2 trial in China
(CTR20170361) of tislelizumab in combination with chemotherapy
enrolled 54 patients with previously untreated locally advanced or
metastatic lung cancer. All patients received tislelizumab at 200
mg every three weeks, plus platinum doublet until disease
progression. Patients with non-squamous non-small cell lung cancer
(NSCLC) (n=16) received pemetrexed plus platinum; patients with
squamous NSCLC received either paclitaxel plus platinum (cohort A,
n=15) or gemcitabine plus platinum (cohort B, n=6); and patients
with small cell lung cancer (SCLC) received etoposide plus platinum
(n=17).
As of the June 5, 2018 data cutoff, 35 patients
remain on treatment. Treatment discontinuation due to adverse
events (AEs) occurred in three patients. Fifty-one patients had at
least one post-baseline tumor assessment and were evaluable for
efficacy. Objective responses (including confirmed and unconfirmed
partial responses) were observed in 56 percent (31 percent
confirmed; all patients with an unconfirmed partial response
remained on treatment) of 16 evaluable patients with non-squamous
NSCLC; 80 percent (all confirmed) in 15 evaluable patients with
squamous NSCLC, cohort A; 67 percent (all confirmed) in six
patients with squamous NSCLC, cohort B; and 82 percent (47 percent
confirmed; all patients with an unconfirmed partial response
remained on treatment) in 17 evaluable patients with SCLC. Data
continue to mature with follow-up.
AEs were considered manageable and reversible, with
chemotherapy dose modifications or tislelizumab dose holds, except
for one fatal event of myocarditis/myositis. Five patients (9.3%)
experienced at least one grade ≥3 AE (polymyositis, dyspnea,
rhabdomyolysis, myocarditis/myositis, and myasthenia gravis) that
were considered to be possibly related to tislelizumab.
Immune-related AEs (irAEs) occurred in 13 patients (24%) and
included hypothyroidism (n=3), decreased tri-iodothyronine (n=2),
hyperthyroidism (n=2), pneumonitis (n=2), pyrexia (n=2), and rash
(n=2).
“We are excited by the preliminary data of
tislelizumab combined with chemotherapy in patients with advanced
lung cancer. The safety and tolerability appear consistent with
previous data, and high response rates of up to 80 percent in a
squamous NSCLC cohort along with low discontinuation rates support
continued investigation of tislelizumab in patients with advance
lung cancer. We are hopeful that this combination therapy will
offer improved outcomes in this advanced disease setting,” said
Professor Jie Wang, M.D., from the National Cancer Center/Cancer
Hospital, Chinese Academy of Medical Sciences and Peking Union
Medical College in Beijing, China, and lead author of the
presentation.
Summary of Preliminary Results of
Tislelizumab in Chinese Patients with NSCLC from Phase 1/2
Trial
The multi-center, open-label Phase 1/2 trial in
China (CTR20160872) of tislelizumab enrolled 46 patients with NSCLC
in the Phase 2 indication expansion portion of the trial, with 21
patients having expression of PD-L1 in 10 percent or more of their
tumor cells (PD-L1+); the remaining 25 patients were considered
PD-L1 negative (PD-L1-).
As of the May 11, 2018 data cutoff, 15 patients
(33%) remained on treatment with the median treatment duration of
4.1 months (0.2–11.3 months) and a median follow-up of 8.4 months
(0.2–11.8 months). Treatment discontinuation due to adverse events
(AEs) occurred only in one patient. The median duration of
treatment was 3.5 months (0.2-11.2 months) and 4.4 months (0.7–11.3
months) in PD-L1+ and PD-L1- cohorts, respectively. A total of 42
patients had at least 1 post-baseline tumor assessment and were
evaluable for antitumor activity. Confirmed partial responses were
observed in 17 percent of the evaluable patients, including 12
percent and 20 percent in PD-L1+ and PD-L1- patients,
respectively.
Across the two arms, the most common
treatment-related AEs (TRAEs) (occurring in ≥ 10% of patients) were
increased transaminases (26%), rash (11%) and hypothyroidism (11%).
A total of 14 patients had serious AEs and three of these patients
experienced serious TRAEs, including nausea and vomiting (n=1),
increased aspartate aminotransferase (AST) (n=1) and hyperglycemia
(n=1). Three patients experienced a serious AE with a fatal outcome
(multiple organ dysfunction syndrome [n=1], central nervous system
metastases [n=1], hypotension [n=1]); none were determined to be
related to treatment. Immune-related AEs occurred in 26 patients
(57%) and many were overlapping with the TRAE cases.
“The prognosis for patients
with late stage non-small cell lung cancer remains particularly
poor. We are pleased that this trial demonstrated that treatment
with tislelizumab was generally well tolerated. We are excited to
see that Phase 3 trials evaluating tislelizumab, either as
monotherapy or in combination with chemotherapy, in patients with
advanced NSCLC are underway and look forward to the results,” said
Yi-Long Wu, M.D., President of Chinese Thoracic Oncology Group
(CTONG) and lead author of the presentation.
Trial data with the same cut off time will be
presented at the International Association for the Study of Lung
Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC), which
takes place September 23-26 in Toronto.
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
Contact |
Craig West |
Liza Heapes |
+1 857-302-5189 |
+ 1 857-302-5663 |
ir@beigene.com |
media@beigene.com |
i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of
Celgene Corporation.
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