SUZHOU, China, May 6, 2020
/PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX:
01801), a world-class biopharmaceutical company that develops,
manufactures and commercializes high quality medicines for the
treatment of cancer, autoimmune, metabolic and other major
diseases, today jointly announced with Eli Lilly and Company
("Lilly", NYSE: LLY) the results of a phase 3 study in China. The ORIENT-12 trial of TYVYT®
(sintilimab injection) in combination with Gemzar® (gemcitabine for
injection) and platinum chemotherapy in first-line advanced or
metastatic squamous non-small cell lung cancer (sqNSCLC) met the
predefined primary endpoint of progression-free survival
(PFS). This is the first randomized, double-blind phase 3
study evaluating the combination of anti-PD-1 antibody with Gemzar
and platinum chemotherapy in the world.
TYVYT in combination with
gemcitabine and platinum chemotherapy demonstrated a statistically
significant improvement in PFS compared to placebo in combination
with gemcitabine and platinum chemotherapy, meeting the pre-defined
endpoint. The safety profile of TYVYT in this trial was consistent
with previously reported studies, and no new safety signals were
identified. Relevant data will be presented at an upcoming medical
conference.
Innovent and Lilly will initiate regulatory discussions for
registration with the National Medical Products Administration
(NMPA) of China in the near future.
"Lung cancer is the leading cause of cancer death (25.2%), of
which NSCLC accounts for 80-85 percent, with about 35 percent of
those patients having the squamous subtype. In the past 20 years,
drug development to treat NSCLC has been mainly focused on
nonsquamous NSCLC, while drug development of sqNSCLC has been
slower due to its lack of driving mutation and its unique
epidemiological, histopathological and molecular characteristics,"
Professor Caicun Zhou, Head of Department of Oncology, Shanghai
Pulmonary Hospital. "The emergence of the anti-PD-1 antibody has
brought a new treatment modality for patients with sqNSCLC. We are
delighted to see that TYVYT in combination with gemcitabine and
platinum chemotherapy has met the predefined primary endpoint in
the ORIENT-12 study. Different from the KEYNOTE-407 study in a
different chemotherapy regimen, ORIENT-12 has demonstrated for the
first time significant PFS benefit with a PD-1 inhibitor in
combination with gemcitabine and platinum in first-line
sqNSCLC."
"Sintilimab is the only anti-PD-1 monoclonal antibody included
in the New Catalogue of the National Reimbursement Drug List
(NRDL). It was officially approved by the NMPA in 2018 for the
treatment of relapsed or refractory classic Hodgkin's lymphoma
after second-line or later systemic chemotherapy," said Dr.
Hui Zhou, Vice President and Head of
Oncology Strategy and Medical Sciences of Innovent. "Currently, we
have several phase 3 randomized clinical trials ongoing in lung
cancer. With the encouraging result of ORIENT-12 we are hopeful
that sintilimab has the potential to benefit more patients with
squamous NSCLC. For Innovent, this is the second randomized study
of NSCLC that met its primary endpoint; the first was ORIENT-11, a
randomized Phase 3 study of 1L non-squamous NSCLC
(NCT03607539)."
"The Center for Drug Evaluation, NMPA just recently accepted a
new drug application for sintilimab in combination with pemetrexed
and platinum chemotherapy as first-line treatment for
nonsquamous NSCLC. The promising results we see in the ORIENT-12
study demonstrate sintilimab's potential in sqNSCLC," said Dr.
Li Wang, Senior Vice-President of
Lilly China and Head of Lilly China
Drug Development and Medical Affairs Center. "We would like to
express our gratitude to the patients and their families,
investigators and clinical trial sites participating in the study,
and to our colleagues from Innovent. We look forward to bringing
this new treatment option to lung cancer patients in China."
About the ORIENT-12 Trial
ORIENT-12 is a randomized, double-blind, Phase 3 study to
evaluate the efficacy and safety of TYVYT® (sintilimab injection)
or placebo in combination with Gemzar® (gemcitabine for
injection) and platinum chemotherapy as first-line therapy for
locally advanced or metastatic sqNSCLC (ClinicalTrials.gov,
NCT03629925). The primary endpoint is progression-free survival
(PFS) assessed by Independent Radiographic Review Committee (IRRC)
based on RECIST v1.1. The secondary endpoints include overall
survival (OS) and safety profile.
A total of 357 subjects have been enrolled in ORIENT-12 trial
and randomized in a 1:1 ratio to receive either TYVYT® (sintilimab
injection) 200mg or placebo in combination with Gemzar®
(gemcitabine for injection) and platinum chemotherapy every 3
weeks for 4 - 6 cycles, followed by either TYVYT® (sintilimab
injection) or placebo maintenance therapy. The subjects will
receive treatment until radiographic disease progression,
unacceptable toxicity or any other conditions that require
treatment discontinuation. Conditional crossover is permitted.
About sqNSCLC
Lung cancer is a malignancy with the highest morbidity and
mortality in China. NSCLC accounts
for about 80 percent to 85 percent of lung cancer. Approximately 70
percent of NSCLC are locally advanced or metastatic at initial
diagnosis, resulting in patients having little to no chance of
radical resection. Meanwhile, even after radical surgery, patients
still have a high chance of recurrence and eventually die from
disease progression. About 35 percent of NSCLC in China are squamous subtype. Squamous NSCLC
lacks a driver mutation, and response rate of first-line
chemotherapy is approximately 30 percent. So far pembrolizumab in
combination with carboplatin and paclitaxel is the only regimen
with PD-1 antibody approved by FDA and NMPA for first-line sqNSCLC.
There remains still a huge unmet medical need.
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection), an innovative drug developed with
global quality standards jointly developed in China by Innovent and Lilly, has been granted
marketing approval by the NMPA for relapsed or refractory classic
Hodgkin's lymphoma after second-line or later systemic
chemotherapy, and included in the 2019 Guidelines of Chinese
Society of Clinical Oncology for Lymphoid Malignancies. TYVYT®
(sintilimab injection) is the only PD-1 inhibitor that has
been included in the new Catalogue of the National Reimbursement
Drug List (NRDL) in November
2019.
TYVYT® (sintilimab injection) is a type of
immunoglobulin G4 monoclonal antibody, which binds to PD-1
molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1
(PD-L1) pathway and reactivates T-cells to kill cancer cells.
Innovent is currently conducting more than 20 clinical studies with
TYVYT® (sintilimab injection) to evaluate its safety and
efficacy in a wide variety of cancer indications, including more
than 10 registration or pivotal clinical trials.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through
Action," Innovent's mission is to develop, manufacture and
commercialize high quality biopharmaceutical products that are
affordable to ordinary people. Established in 2011, Innovent is
committed to developing, manufacturing and commercializing high
quality innovative medicines for the treatment of oncology,
autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main
Board of the Stock Exchange of Hong Kong Limited with the stock
code: 01801.HK.
Since its inception, Innovent has developed a fully-integrated
multifunctional platform which includes R&D, CMC (Chemistry,
Manufacturing, and Controls), clinical development and
commercialization capabilities. Leveraging the platform, the
company has built a robust pipeline of 23 valuable assets in the
fields of oncology, autoimmune, metabolic diseases and other major
therapeutic areas, with 16 in clinical development, 5 in Phase 3 or
pivotal clinical trials, 4 under NDA reviews by the NMPA with
priority review status, while TYVYT® (sintilimab injection),
officially approved for marketing in China in 2018, has been the only PD-1
inhibitor included in the NRDL since 2019.
Innovent has built an international team of advanced talents in
high-end biological drug development and commercialization,
including many overseas experts. The company has also entered into
strategic collaborations with Eli Lilly and Company, Adimab,
Incyte, Hanmi and other international pharmaceutical companies.
Innovent strives to work with all relevant parties to help advance
China's biopharmaceutical industry, improve drug availability to
ordinary people and enhance the quality of the patients' lives. For
more information, please visit: www.innoventbio.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to create medicines to make life better for people around
the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.com and
http://newsroom.lilly.com/social-channels.
About Innovent Biologics' strategic cooperation with Eli
Lilly and Company
Innovent entered into a strategy collaboration with Lilly
focusing on biological medicine in March
2015 – a groundbreaking partnership between a Chinese
pharmaceutical company and a multinational pharmaceutical company.
Under the agreement, Innovent and Lilly will co-develop and
commercialize oncology medicines, including TYVYT® (sintilimab
injection) in China. In
October 2015, the two companies
announced the extension of their existing collaboration to include
co-development of three additional oncology antibodies targeting
oncology indications. In August 2019,
Innovent further entered a licensing agreement with Lilly to
develop and commercialize a potentially global best-in-class
diabetes medicine in China. Its
collaboration with Lilly indicates that Innovent has established a
comprehensive level of cooperation between China's innovative
pharmaceuticals sector and the international pharmaceuticals sector
in fields such as R&D, CMC, clinical development and
commercialization.
GEMZAR® is a registered trademark owned by or
licensed to Eli Lilly and Company, its subsidiaries, or
affiliates
Disclaimer:
1. This indication is still under clinical trial, which
hasn't been approved in China.
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SOURCE Innovent Biologics, Inc.