SUZHOU, China, May 31, 2020 /PRNewswire/ -- Innovent Biologics,
Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical
company that develops, manufactures and commercializes high quality
medicines, jointly announced with Eli Lilly and Company (Lilly)
(NYSE: LLY) the results of TYVYT® (sintilimab injection) ORIENT-2
study, a pivotal clinical study of second-line treatment for
locally advanced or metastatic esophageal squamous cell carcinoma
(ESCC) at the 56th Annual Meeting of the American
Society of Clinical Oncology (ASCO) (Abstract # 4511, Poster # 119,
8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).
The ORIENT-2 study was a randomized, open-label, multicenter,
Phase 2 clinical study comparing the efficacy and safety of
sintilimab with chemotherapy (paclitaxel or irinotecan) in patients
with advanced or metastatic ESCC whose disease progressed on
first-line therapy. A total of 190 subjects were enrolled in the
study and randomly assigned in a 1:1 ratio to receive either
sintilimab injection or chemotherapy (paclitaxel or irinotecan).
The study's primary endpoint was overall survival (OS).
As of August 2, 2019, compared
with paclitaxel/irinotecan, sintilimab demonstrated a statistically
significant improvement in OS in the intent-to-treat (ITT)
population (HR = 0.70, P = 0.032). The median OS in the
sintilimab-treated group and the chemotherapy-treated group were
7.2 months and 6.2 months and the 12-month OS rates were 37.4% and
21.4%, respectively, showing encouraging antitumor efficacy in the
sintilimab-treated group. The safety profile of sintilimab in this
study of ESCC patients was similar to that seen in studies of
sintilimab in other tumors.
Professor Jianming Xu, Director
of the Department of Gastrointestinal Oncology at the Fifth Medical
Center of PLA General Hospital, said: "For patients with advanced
or metastatic ESCC who have progressed on first-line treatment,
there are few next treatment options and traditional chemotherapy
drugs have shown a very limited effect. The ORIENT-2 study
confirmed that sintilimab can prolong OS compared with chemotherapy
(paclitaxel or irinotecan) in the second-line treatment of patients
with ESCC. We are hopeful that sintilimab can be used as an
effective treatment option for the second-line treatment of ESCC,
bringing more clinical benefits to patients in need."
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection), an innovative drug developed with
global quality standards jointly developed by Innovent and Lilly in
China, has been granted marketing
approval by the National Medical Products Administration (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 17 in clinical development, five in Phase 3
or pivotal clinical trials, four under NDA reviews by the NMPA
(three under 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, 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 Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to create medicines that 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.
About Innovent Biologics' strategic cooperation with Eli
Lilly and Company
Innovent entered into a strategic 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 are co-developing and
commercializing 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 antibodies targeting oncology
indications. In August 2019, Innovent
entered into an additional 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.
View original
content:http://www.prnewswire.com/news-releases/innovent-biologics-and-lilly-jointly-announced-the-pivotal-clinical-study-results-of-tyvyt-sintilimab-injection-in-the-second-line-treatment-of-patients-with-locally-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-301068200.html
SOURCE Innovent Biologics, Inc.