SAN FRANCISCO and SUZHOU,
China, May
18, 2021 /PRNewswire/ -- Innovent Biologics, Inc.
(HKEX: 01801) and Eli Lilly and Company (NYSE: LLY) today jointly
announced that the U.S. Food and Drug Administration (FDA) accepted
for review a Biologics License Application
(BLA) for sintilimab injection in combination with
pemetrexed and platinum chemotherapy for the first-line treatment
of people with nonsquamous non-small cell lung cancer (NSCLC). This
is the first U.S. regulatory submission of sintilimab, a PD-1
inhibitor being developed and commercialized under a global
collaboration agreement between Innovent and Lilly.
"The acceptance of this application – the first for sintilimab
in the U.S. and outside of China –
is an important milestone in Innovent's global commercialization
strategy and in our collaboration with Lilly," said Dr.
Yongjun Liu, president of Innovent.
"We look forward to working closely with the FDA to potentially
bring this sintilimab-pemetrexed-platinum chemotherapy combination
as a treatment option in the U.S., following the regimen's
regulatory approval in China
earlier this year."
Sintilimab is currently being evaluated
in a wide variety of cancer types under a broad clinical
development program. To date, sintilimab has two indications
approved in China, three
regulatory submissions under review in China, and this regulatory application under
review in U.S.. This regulatory application was submitted to the
FDA in March 2021, primarily based on
the results of the Phase 3 ORIENT-11 trial. The Prescription Drug
User Fee Act (PDUFA) goal date for the FDA to make a decision on
the sintilimab application is in March
2022. The FDA stated that it did not identify any potential
review issues in its acceptance letter. It is currently planning to
hold an Advisory Committee meeting to discuss this
application.
"We are pleased the sintilimab submission is progressing. Our
pursuit of this proposed indication in the U.S. reinforces Lilly's
and Innovent's joint commitment to offer additional therapeutic options for people
living with lung cancer and the healthcare providers who treat
them," said Anne White, president, Lilly Oncology. "This
is an encouraging start for our collaborative efforts to make
sintilimab available in countries beyond China, as we continue to pursue opportunities
globally for this immuno-oncology medicine across various tumor
types."
About the ORIENT-11 Trial
ORIENT-11 is a randomized, double-blind, Phase 3 clinical
trial assessing the efficacy and safety of sintilimab in
combination with pemetrexed and platinum chemotherapy compared to
placebo in combination with pemetrexed and platinum chemotherapy as
a first-line treatment for patients with advanced or metastatic
nonsquamous non-small cell lung cancer (NSCLC), with no sensitizing
EGFR mutations or ALK rearrangements. The primary endpoint is
progression-free survival (PFS) as assessed by Independent
Radiographic Review Committee (IRRC) based on RECIST v1.1., and
secondary endpoints include overall survival (OS) and safety
profile.
A total of 397 patients were enrolled and randomized 2:1 to
receive either sintilimab 200mg or placebo in combination with
pemetrexed and platinum chemotherapy every three weeks for up
to four cycles, followed by either sintilimab or placebo plus
pemetrexed maintenance therapy. Patients received treatment until
radiographic disease progression, unacceptable toxicity or any
other conditions that required treatment discontinuation.
Conditional crossover was permitted. The results of the ORIENT-11
study were published in 2020.1
About Lung Cancer
Globally, lung cancer is the leading cause of cancer death,
killing nearly 1.8 million people worldwide each year. In
the U.S., lung cancer is the second most common cancer (not
counting skin cancer) and the leading cause of cancer death,
responsible for nearly 25 percent of all cancer deaths – more than
those from colorectal, breast and prostate cancers
combined. Non-small cell lung cancer (NSCLC) accounts for
approximately 85 percent of all lung cancers, and about 70 percent
of those with NSCLC have the nonsquamous subtype. Fifty percent of
NSCLC patients present with advanced or metastatic disease at
diagnosis.
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in
China, is an innovative PD-1
inhibitor with global quality standards jointly developed by
Innovent and Lilly. Sintilimab 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 of sintilimab to evaluate
its safety and efficacy in a wide variety of cancer indications,
including more than 10 registrational or pivotal clinical
trials.
In China, sintilimab has been
approved for:
- The treatment of relapsed or refractory classic Hodgkin's
lymphoma after two lines or later of systemic chemotherapy
- In combination with pemetrexed and platinum chemotherapy, for
the first-line treatment of nonsquamous non-small cell lung
cancer
Additionally, Innovent currently has regulatory submissions
under review in China for
sintilimab:
- In combination with gemcitabine and platinum chemotherapy, for
the first-line treatment of squamous non-small cell lung
cancer
- In combination with BYVASDA® (bevacizumab injection) for the
first-line treatment of hepatocellular carcinoma
- The second-line treatment of squamous non-small cell lung
cancer
In May 2021, the U.S. FDA accepted
for review the Biologics License Application (BLA) for sintilimab
in combination with pemetrexed and platinum chemotherapy for
the first-line treatment of nonsquamous
non-small cell lung cancer.
Sintilimab was included in China's National Reimbursement Drug List
(NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1
included in the list in that year.
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 cancer,
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
multi-functional 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 cancer, metabolic, autoimmune diseases and other major
therapeutic areas, with four products – TYVYT® (sintilimab
injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO®
(adalimumab biosimilar injection) and HALPRYZA® (rituximab
biosimilar injection) – officially approved for marketing in
China, five assets in Phase 3 or
pivotal clinical trials, and an additional 14 molecules in clinical
trials.
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, MD Anderson Cancer Center, Hanmi and other international
partners. 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 Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering
life-changing medicines and support to people living with cancer
and those who care for them. Lilly is determined to build on this
heritage and continue making life better for all those affected by
cancer around the world. To learn more about Lilly's commitment to
people with cancer, please visit www.LillyOncology.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 www.lilly.com and lilly.com/newsroom.
About Innovent Biologics' Strategic Collaboration with Eli
Lilly and Company
Innovent entered into a strategic collaboration with Lilly
focused 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 are co-developing and
commercializing oncology medicines, including sintilimab 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. In August 2020,Lilly and
Innovent announced a global expansion of their strategic alliance
for sintilimab, whereby Lilly obtained an exclusive license for
sintilimab for geographies outside of China.
Note:
TYVYT® (sintilimab injection; Innovent), BYVASDA®
(bevacizumab biosimilar injection; Innovent), SULINNO®
(adalimumab biosimilar injection; Innovent), and HALPRYZA®
(rituximab biosimilar injection; Innovent) are not approved
products in the United States.
Innovent Biologics, Inc.
Forward-Looking Statements
This news release may contain certain forward-looking statements
that are, by their nature, subject to significant risks and
uncertainties. The words "anticipate", "believe", "estimate",
"expect", "intend" and similar expressions, as they relate to
Innovent, are intended to identify
certain of such forward-looking statements. Innovent does not intend to update these
forward-looking statements regularly.
These forward-looking statements are based on the existing
beliefs, assumptions, expectations, estimates, projections and
understandings of the management of Innovent with respect to future events at
the time these statements are made. These statements are not a
guarantee of future developments and are subject to risks,
uncertainties and other factors, some of which are beyond Innovent's control and are difficult to
predict. Consequently, actual results may differ materially from
information contained in the forward-looking statements as a result
of future changes or developments in our business, Innovent's competitive environment and
political, economic, legal and social conditions.
Innovent, the Directors and the
employees of Innovent assume
(a) no obligation to correct or update the forward-looking
statements contained in this site; and (b) no liability in the
event that any of the forward-looking statements does not
materialise or turn out to be incorrect.
Eli Lilly and Company
Forward-Looking Statement
This press release contains
forward-looking statements (as that term is defined in the Private
Securities Litigation Reform Act of 1995) about sintilimab
injection in combination with pemetrexed and platinum chemotherapy
as a potential first-line treatment of people with nonsquamous
non-small cell lung cancer and reflects Lilly's current beliefs and
expectations. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of drug
research, development, and commercialization. Among other things,
there can be no guarantee that future study results will be
consistent with study results to date, or that sintilimab will
receive additional regulatory approvals or be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's most recent Form 10-K and Form 10-Q
filings with the United States Securities and Exchange Commission.
Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
[1] Yang Y, Wang Z, Fang J, Yu Q, Han B, Cang S, Chen G, Mei
X, Yang Z, Ma R, Bi M, Ren X, Zhou J, Li B, Song Y, Feng J, Li J,
He Z, Zhou R, Li W, Lu Y, Wang Y, Wang L, Yang N, Zhang Y, Yu Z,
Zhao Y, Xie C, Cheng Y, Zhou H, Wang S, Zhu D, Zhang W, Zhang L.
Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as
First-Line Treatment for Locally Advanced or Metastatic Nonsquamous
NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram
by InnovENT anti-PD-1-11). J Thorac Oncol. 2020
Oct;15(10):1636-1646. doi: 10.1016/j.jtho.2020.07.014. Epub 2020
Aug 8.
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