SUZHOU, China, Sept. 20, 2018 /PRNewswire/ -- Innovent Biologics, Inc.
(Innovent), a world-class China-based biopharmaceutical company that
develops and commercializes high quality drugs, today presented
clinical research data on cohort C at the 2018 Annual Meeting of
Chinese Society of Clinical Oncology (CSCO). The study is a phase
Ib clinical trial (NCT02937116) in which NSCLC patients with
disease progression failed from prior therapy were treated with
sintilimab (a fully human anti-programmed cell death 1 monoclonal
antibody).
37 patients who had progressed on at least one line of prior
therapies were enrolled, and 34 patients have had at least one
radiological assessment. Patients receiving sintilimab monotherapy
enjoyed an objective response rate (ORR) of 17.6% based on irRECIST
criteria, a median progression free survival (PFS) of 2.8 months,
medium overall survival of 13.8 months and as of the medium
follow-up time of 8.4 months.
The incidence and severity of adverse events were comparable
with other anti-PD1 products. The relationship between tumor
mutation burden (TMB) and efficacy of sintilimab was also explored
by analyzing TMB level in 25 patients. Among 6 patients whose TMB
level was high (>12 mutations/Mb), ORR was 50%, and disease
control rate (DCR) was 100%.
ORIENT-3, an open-label, multi-center, randomized Phase III
clinical trial, which compares the efficacy and safety of
sintilimab to docetaxel in patients with advanced or metastatic
squamous NSCLC who had disease progression on first-line
platinum-based therapy is ongoing in China.
"We have seen good efficacy and safety in several clinical
trials on lung cancer carried out by Innovent. As a physician, it
is our relentless pursuit to explore safer and more effective
treatments to help the patient with malignant tumors to obtain a
healthier and longer life. We have great expectations for
sintilimab and hope to see more positive result in the future
clinical trials, which will benefit more patients and families
soon," said Professor Li Zhang, from
the Sun Yat-Sen University Cancer Center.
"Lung cancer has the highest morbidity and mortality among
malignant tumors in China, we are
delighted to witness the efficacy and safety profile of sintilimab
for standard treatment failed NSCLC," said Michael Yu, Founder, Chief Executive Officer and
Chairman of Innovent, "At present, the phase III study of the
second line squamous NSCLC is progressing smoothly, and we hope to
provide more treatment options for lung cancer patients in the
future."
About Advanced or Recurrent Non-squamous
Non-Small Cell Lung Cancer
Lung cancer has the highest incidence and mortality among all
malignancies in China. NSCLC
accounts for about 80% to 85% of all lung cancer cases, and at
diagnosis about 70% of NSCLC patients are locally advanced or
metastatic, with a 5 year overall survival rate less than 20%. Even
patients with early-stage NSCLC who undergo successful surgery are
at high risk of recurrence and metastasis, resulting in a 5 year
overall survival rate of 50%. In China, squamous NSCLC represents 30% of total
NSCLC. Patients who have failed standard treatment have high unmet
medical needs.
About Sintilimab
Sintilimab is a fully human anti-PD-1 antibody. It binds to the
PD-1 receptor on T cells, blocking the PD-L1 ligand from
interacting with PD-1 to help restore T-cell response and immune
response, thus destroying the tumor cells. Sintilimab is an
anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli
Lilly and Company in China.
National Medical Products Administration (NMPA, formerly known as
CFDA) accepted the New Drug Application (NDA) submitted by Innovent
for sintilimab on April 16, 2018, and
granted it priority review status on April
23, 2018. The indication for the first new drug application
is relapsed/refractory classical Hodgkin's Lymphoma.
About Innovent
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. Since its establishment from 2011, Innovent has developed a
fully-integrated platform which includes R&D, CMC (Chemistry,
Manufacturing, and Controls), clinical development and
commercialization capabilities, and a pipeline of innovative and
commercially promising monoclonal antibodies and other biologics in
the fields of oncology, ophthalmology, autoimmune and metabolic
diseases. Innovent has built up a pipeline of 17 antibody drug
candidates, with four core products in late-stage clinical
development in China and one that
has a New Drug Application (NDA) accepted by the NMPA with priority
review status.
Innovent has a highly talented international team, including
many expert returnees with experience in innovative
biopharmaceutical drug discovery, development, production and
commercialization. The company has also entered into various key
strategic alliances with Eli Lilly and Company, Adimab, and other
biopharmaceutical companies. Innovent has raised 580 million USD in private financing from
numerous world-renowned VC or PE firms, including Eight Roads and
F-Prime Capital (which form part of the proprietary investment
business of Fidelity), Lilly Asia Ventures, Capital Group, Legend
Capital, Temasek, Rock Springs Capital, Cormorant Private
Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State
Development & Investment Corporation.
About the partnership between Innovent Biologics and 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 to provide support to 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 partnerships 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:
Email: ir@innoventbio.com
Tel: 86 512 6956 6088
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SOURCE Innovent Biologics, Inc.