SUZHOU, China, Jan. 16,
2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent)
(HKEX: 01801), a world-class biopharmaceutical company that
develops and commercializes high quality medicines, announced today
that the first patient has been dosed in a phase III clinical trial
(ORIENT-16) that is to evaluate Tyvyt® (fully human
anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab
injection), in combination with capecitabine and oxaliplatin, as
first-line treatment for patients with advanced, recurrent or
metastatic gastric or gastroesophageal junction adenocarcinoma (GC
or GEJ).
The ORIENT-16 study is a randomized, double-blind, multi-center,
phase III trial conducted in China
to evaluate the efficacy and safety of Tyvyt®
(sintilimab injection) or placebo in combination with chemotherapy
as first-line treatment in subjects with unresectable, locally
advanced, recurrent or metastatic GC or GEJ. The phase III study
will enroll 650 patients. The study follows a phase Ib study that
evaluated Tyvyt® (sintilimab injection) in combination
with chemotherapy in patients with gastric cancer.
"Over the past decade, the treatment of various malignant tumors
has progressed rapidly. From traditional chemotherapy to targeted
molecular therapy and immunotherapy, the prognosis of cancer
patients has been improved remarkably. However, breakthroughs in
the treatment of gastric cancer have been few. With the exception
of trastuzumab in first-line use for HER-2 positive patients,
several phase III clinical trials have failed successively. Based
on the efficacy signals and the safety profile from previous
trials, we hope to validate the therapeutic potential of sintilimab
in combination with chemotherapy in ORIENT-16, a phase III trial,"
said Dr. Jianming Xu, a professor
from the Chinese PLA General Hospital.
"Gastric cancer is the second most common malignant tumor in
China. The development of new
agents for the treatment of advanced gastric cancer has been
stagnant, and unmet clinical need is huge. Based on the encouraging
efficacy signal we have observed in our phase Ib study, we have
decided to conduct ORIENT-16, a phase III study in first-line
gastric cancer. Our goal is to provide more effective cancer
treatment options for the benefit of these patients and for their
families," said Michael Yu, Founder,
Chief Executive Officer and Chairman of Innovent.
About Tyvyt® (sintilimab injection)
Tyvyt® (sintilimab injection) is an innovative drug
jointly developed by Innovent and Eli Lilly and Company in
China. Tyvyt®
(sintilimab injection) is a type of immunoglobulin G4 monoclonal
antibody, which binds to the PD-1 molecule on the surface of
T-cells, blocks the PD-L1(Programmed Cell Death-1 Ligand-1, PD-L1
pathway)and reactivates T-cells to kill cancer cells.
Tyvyt® (sintilimab injection) is the only PD-1 antibody
in China branded by both a local
biopharmaceutical company and a global pharmaceutical company.
About ORIENT-16 Study
The ORIENT-16 study is a randomized, double-blind, multi-center,
phase III trial which evaluates the efficacy and safety of
Tyvyt® (sintilimab injection) or placebo in combination
with chemotherapy as first-line treatment in subjects with
unresectable, locally advanced, recurrent or metastatic GC or GEJ.
Patients will receive Tyvyt® (sintilimab injection) or
placebo in combination with capecitabine and oxaliplatin, followed
by Tyvyt® (sintilimab injection) or placebo and
capecitabine until disease progression. Participants will be
randomly assigned in a 1:1 ratio into the experimental or control
groups. The study will enroll 650 patients. The primary endpoints
are overall survival in both the entire population and in PD-L1
positive population of patients.
About Advanced, Recurrent or Metastatic Gastric Cancer (GC)
Gastric cancer is one of the most common malignant tumors
worldwide, ranking fifth in incidence and third in cancer-related
deaths. More than half of the cases and deaths from gastric cancer
occur in China. Many patients have
advanced disease at the initial diagnosis and have little
opportunity for therapy with curative intent. The prognosis of
patients with advanced and metastatic gastric cancer is poor with
an overall survival less than 12 months.
About Innovent
Innovent was established in 2011. Since it was founded, Innovent
has developed a fully-integrated platform which includes R&D,
CMC (Chemistry, Manufacturing, and Controls), clinical development
and commercialization capabilities. These capabilities have enabled
the company to build a robust pipeline of innovative and
commercially promising monoclonal antibodies and other biologics in
the fields of oncology, ophthalmology, autoimmune, and
cardiovascular diseases. Leveraging the platform, the company has
built up a pipeline of 20 innovative medicines in the last seven
years, led by four core products that are in late-stage clinical
development in China. Out of the
pipeline of 20 innovative medicines, thirteen have entered into
clinical development, four have entered Phase III clinical trials,
one (biosimilar to Humira) has its New Drug Application (NDA) under
review and Tyvyt® (sintilimab injection) is now approved
for relapsed or refractory classical Hodgkin's lymphoma (r/r
cHL).
Innovent has built a biopharmaceutical production facility that
operates under global standards. The design and operation of the
clinical and commercial facilities are in compliance with the cGMP
standards of NMPA, FDA and EMA. The existing production lines have
already passed GMP audits by an international pharmaceutical
company. The company has also entered into various key strategic
alliances with Eli Lilly and Company, Adimab, Incyte, Hanmi and
other biopharmaceutical companies.
Inspired by the spirit of "Start with Integrity, Succeed through
Action", Innovent's mission is to develop and commercialize high
quality biopharmaceutical products that are affordable to ordinary
people. Innovent wishes to work with all relevant parties helping
the advancement of China's
biopharmaceutical industry, improving the drug availability to
ordinary people and enhancing the quality of the patients'
life.
Innovent is listed on the main board of the Hong Kong Stock
Exchange with the stock code of HK 01801.
For more information, please visit:www.innoventbio.com.
About Innovent Biologics' strategic collaboration with Eli Lilly
and Company
Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent)
in March 2015 announced one of the
largest biotech drug development collaborations in China to date between a multi-national and
domestic company. Under the terms of the agreement, Lilly and
Innovent shall collaborate on the development and potential
commercialization of at least three cancer treatments over the next
decade. In October 2015, they
announced an expansion of their drug development collaboration.
These collaborations represent that Innovent has struck one of the
most comprehensive strategic collaborations of any Chinese company
with a multinational partner in terms of the scope and breadth
ranging from discovery to commercialization and involving up to six
therapeutic antibodies for cancers.
For inquiries, please contact:
Tel: +86 512-6956-6088
Email: ir@innoventbio.com
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SOURCE Innovent Biologics, Inc.