SAN FRANCISCO and SUZHOU,
China, Sept. 14, 2020 /PRNewswire/ -- Innovent
Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class
biopharmaceutical company that develops, manufactures and
commercializes high quality medicines for treatment of oncology,
metabolic, autoimmune and other major diseases, and Eli Lilly and
Company ("Lilly", NYSE: LLY) jointly announce that results of six
clinical studies of TYVYT® (sintilimab injection) will be presented
during the upcoming European Society of Medical Oncology ("ESMO")
Virtual Congress 2020 from September 19th to 21st. The annual ESMO conference is among the most
prestigious and influential global
oncology conferences, during which
oncologists around the world will share the latest research
progress in cancer treatments.
The six sintilimab studies
to be presented at ESMO Virtual Congress include two LBAs
(late-breaking abstracts, mini oral) and four e-posters (including two ongoing Phase 3 studies). The studies cover
indications including lung cancer, gynecological cancer,
hepatocellular carcinoma, gastric cancer, and other solid tumors. A
brief summary of the studies is as follows:
Cancer Type: Lung Cancer
Presentation type: LBA (mini oral)
Biomarker Results from the
ORIENT-11 Study (NCT 03607539): Finding biomarkers to accurately
predict the efficacy of Immuno-combination therapy is still a
hotspot and difficult issue in the study of PD-1 inhibitors. In the
ORIENT-11 study, sequencing was conducted on baseline tumor
biopsies to explore the association between immune related genes
and clinical efficacy. The results could improve our understanding
of the mechanism of action of immunotherapy-chemotherapy
combination and provide a scientific rationale for future selection
of suitable patients.
Researcher: Professor Yunpeng
Yang, Sun Yat sen University
cancer center
Results of the ORIENT-12 Study (NCT03629925): sintilimab plus
gemcitabine and platinum chemotherapy as first-line treatment for
locally advanced or metastatic squamous non-small-cell lung cancer
(sqNSCLC). Clinical benefit from platinum-based chemotherapy for
patients with advanced sqNSCLC is limited. Previous studies have
shown the clinical benefits of the combination therapy of PD-1
inhibitor with paclitaxel/platinum chemotherapy as first-line treatment for
sqNSCLC. In a Phase 1b cohort study, sintilimab in combination with
gemcitabine/platinum chemotherapy
has shown good efficacy and acceptable safety as first-line
treatment for sqNSCLC. ORIENT-12 is a randomized, double-blind,
Phase 3 study evaluating sintilimab or placebo in combination with
gemcitabine and platinum chemotherapy as first-line treatment for
locally advanced or metastatic sqNSCLC. ORIENT-12 has demonstrated for the first
time survival benefit by treatment with PD-1 inhibitor in
combination with gemcitabine and platinum chemotherapy in first-line
sqNSCLC.
Researcher: Professor Caicun Zhou, Shanghai Pulmonary
Hospital, Tongji University
Cancer Type: Hepatocellular carcinoma (HCC)
Presentation Type: e-poster
Sintilimab plus IBI305 (bevacizumab) as the first-line treatment
for advanced HCC (NCT03794440). So far the treatment of first-line
advanced HCC is limited with feasible choices such as sorafenib or
lenvatinib. Immuno-oncology
inhibitors have shown therapeutic value in HCC, with PD-L1
inhibitor (atezolizumab) in combination with a VEGF inhibitor reporting clinical benefits in unresectable
or metastatic HCC patients before systemic treatment. This study
will announce the safety and preliminary efficacy of combining PD-1
inhibitor and VEGF inhibitor in the first line treatment for
patients with advanced unresectable or metastatic HCC. Currently
sintilimab is undergoing Phase 2/3
study in combination with Byvasda (bevacizumab injection) in
comparison with sorafenib in the first-line treatment of advanced
HCC.
Researcher: Academician Jia Fan, Zhongshan Hospital, Fudan
University
Cancer type: Gastric Cancer
Report type: e-poster
ORIENT-106 Study: To
date, systemic chemotherapy remains the main choice for unresectable locally
advanced or metastatic gastric cancer / gastroesophageal junction
adenocarcinoma (G/GEJ). The prognosis of these patients is poor
with the median overall survival (mOS) only about one year. Preclinical studies have shown
that an anti-VEGF receptor 2 (VEGFR-2) antibody can
restart the tumor microenvironment to avoid immunosuppression of
tumor cells. In clinical studies, it was also observed that
blocking PD-1 and VEGFR-2 at the same time could achieve
synergistic anti-tumor effect. The ORIENT-106 study based on this
theory is a multicenter, randomized, open label Phase 3 clinical trial to verify the
efficacy and safety of sintilimab (IgG4 PD-1 inhibitor) and
ramucirumab (IgG1 VEGFR-2 antagonist) as the first-line treatment
for locally advanced or metastatic G/GEJ.
Researcher: President Ruihua
Xu, Sun Yat sen University
Cancer Center
Cancer type: Gynecological Tumor
Report type: e-poster
There are limited effective treatment for advanced cervical
cancer patients who have previously received platinum-based
chemotherapy. PD-1 inhibitor monotherapy has shown promising
efficacy in patients with cervical cancer with positive PD-L1
expression. The combination of PD-1/PD-L1 inhibitors plus
anti-angiogenesis drugs has shown significant anti-tumor activity
in certain cancers. Professor Qin Xu
from Fujian Cancer Hospital conducted a phase II study of
sintilimab plus anlotinib for the treatment of advanced cervical
cancer with positive PD-L1 expression. The study may potentially
further improve the clinical outcomes of patients with advanced
cervical cancer who have previously received platinum-based
chemotherapy.
Researcher: Professor Qin Xu,
Fujian Cancer Hospital
Cancer type: Solid Tumors
Report type: e-poster
The antitumor effect of chemotherapy combined with either PARP
inhibitors or PD-1 inhibitors have been demonstrated in several
studies, and previous researches have shown a synergetic effect of
PARP inhibitors combining with PD-1 inhibitors. However, little was
known regarding the combination of the three regimens. This is a
phase 1b clinical study initiated by
Professor Hu Yi of the Chinese PLA
General Hospital, exploring the combination of sintilimab, platinum
and niraparib (a PARP1/2 inhibitor) in the treatment of previously
treated advanced solid tumors. The novel triple combination could
potentially overcome resistance and further improve clinical
outcomes of patients with advanced solid tumors who failed standard
therapy.
Researcher: Professor Yi Hu,
Chinese people's Liberation Army General Hospital
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. Established in 2011, Innovent is committed to developing,
manufacturing and commercializing high quality innovative medicines
for the treatment of cancer, metabolic, autoimmune 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 3 products, TYVYT® (sintilimab injection),
BYVASDA® (bevacizumab injection) and SULINNO® (adalimumab
injection), on market, 1 asset under NDA review with priority
review status, 4 assets in Phase III or pivotal clinical trials,
and additional 15 molecules in or close to clinical trials. TYVYT®
(sintilimab injection) has been the only PD-1 inhibitor included in
the NRDL since 2019.
Innovent has built an international team with expertise in
cutting-edge biological drug development and commercialization. The
company has also entered into strategic collaborations with Eli
Lilly, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi
and other international partners. 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.
About Innovent Biologic's 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. In
August 2020, Innovent and Lilly
announced an expansion of their strategic alliance for TYVYT®
(sintilimab injection). 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 areas such as R&D, CMC, clinical development and
commercialization.
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SOURCE Innovent Biologics, Inc.