SUZHOU, China, May 15, 2019 /PRNewswire/ -- Innovent Biologics,
Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical
company that develops and commercializes high quality medicines,
today announced that the research data on the treatment of relapsed
or refractory extranodal NK/T cell lymphoma (ORIENT-4) with
sintilimab, co-developed with Eli Lilly and Company ("Lilly") and
key data from six other clinical studies will be presented at the
55th Annual Meeting of the American Society of Clinical Oncology
(ASCO) by oral presentation and posters.
The results of ORIENT-4 will be presented during an oral session
at the 55th Annual Meeting of the ASCO in Chicago on June 4,
2019 [Abstract #7504; Tuesday, June
4, 10:57 AM -11:09 AM
CDT].
ORIENT-4, the multicenter, single-arm, Phase 2 clinical trial
for relapsed/refractory (r/r) extranodal NK/T cell lymphoma (ENKTL)
in China, evaluates the efficacy
and safety of sintilimab as monotherapy in the treatment in patient
with r/r ENKTL. This trial includes 28 patients with r/r ENKTL who
had treatment progression despite receiving an average of 3
conventional treatments. The primary end point of the trial is the
objective response rate (ORR). According to pre-defined response
criteria 19 patients achieved objective response resulting in a 68%
ORR and 85.7% disease control rate (DCR). (The data was cut-off on
February 2, 2019, when 19 patients
were still on treatment.)
"ENKTL is a rare tumor with a proclivity for East Asians.
Recurrent or refractory patients who are not cured by standard of
care therapy are in urgent need for new drugs with better efficacy
and safety. EB virus infection is common in ENKTL and often results
in immuno-hot tumor phenotype. The ORR of sintilimab in this trial
of r/r ENKTL patients is 68% and most patients have enjoyed disease
control. We are looking forward to studying sintilimab in other
hematological tumors," said Professor Jianyong Li from Department of Haematology,
Jiangsu Province Hospital.
"We are announcing key findings from several clinical studies at
ASCO that demonstrate the significant progress we have made in the
field of tumor immunotherapy. In particular, the results of the
ORIENT-4 study give us hope that sintilimab has the requisite
efficacy, tolerance and safety to become an important player in the
treatment of r/r ENKTL. It could provide a new treatment option to
patients," said Michael Yu, Founder,
Chief Executive Officer and Chairman of Innovent. "Innovent
strives 'to develop and commercialize high quality
biopharmaceuticals that are affordable to ordinary people.' We hope
our efforts contribute new cancer therapeutics by progressing
clinical oncology research in China. "
During the same conference, Innovent will also publish key
findings from the six other clinical studies in posters and other
sessions at the ASCO 2019 Annual Meeting including:
- Efficacy and Safety of Sintilimab in Combination with CAPOX in
First-line Gastric or Gastroesophageal Junction Carcinoma (GC/GEJC)
in Phase 1b Study [Abstract #4042;
Monday, June 3, 8:00 AM -11:00 AM CDT]. Sintilimab is shown to
have favorable efficacy and safety profiles. A randomized, Phase 3
study of sintilimab in combination with CAPOX in first line gastric
cancer is ongoing (NCT03745170).
- Efficacy and Safety of Neoadjuvant PD-1 Blockade with
Sintilimab in Resectable Squamous Non-Small Cell Lung Cancer
(sqNSCLC) [Abstract #8531; Sunday, June
2, 8:00 AM -11:00 AM CDT]. The
trial shows that neoadjuvant sintilimab for sqNSCLC patients is
tolerable and the major pathologic response (MPR) rate is
encouraging.
- Sintilimab for relapsed/refractory classical Hodgkin's
lymphoma: Extended follow-up on the multicenter, single-arm Phase
II ORIENT-1 study [Abstract #7533; Monday,
June 3, 8:00 AM -11:00 AM
CDT]. The trial is the largest clinical trial of classical
Hodgkin's lymphoma patients treated with PD-1 in China. In addition to high objective response
and complete response rates, sintilimab also shows sustained
efficacy and acceptable long-term safety during follow-up.
- Efficacy and safety of IBI305 compared with bevacizumab in
advanced non-squamous NSCLC patients as first-line treatment in a
randomized, double-blind, phase 3 study [Abstract #9095;
Sunday, June 2, 8:00 AM -11:00 AM CDT]. The trial demonstrates
the therapeutic similarities between IBI305 (the biosimilar drug
candidate of bevacizumab) and bevacizumab. The controlled trial has
achieved the predefined primary end points and meets the
prespecified clinical similarity measures for ORR. There are no
significant difference in safety profile and immunogenicity between
the two experimental arms.
- Circulating Tumor DNA Predicts Response and Resistance by
anti-PD-1 Therapy in Chinese Relapsed/Refractory Classic Hodgkin
Lymphoma [Abstract #7534; Monday, June
3, 8:00 AM -11:00 AM CDT]. The
study demonstrated that ctDNA could serve as valuable biomarker for
prediction of response or resistance to anti-PD1
immunotherapy.
- Phase Ib Study of Sintilimab in Combination with Chemotherapy
for 1L Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).
The combination of sintilimab and chemotherapy shows an acceptable
efficacy and safety profile in 1L nsq- and sq-NSCLC (Reference #
e20546). Two Phase 3 trials are ongoing to evaluate the combination
in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925)
respectively.
About ORIENT-4
ORIENT-4 is a multicenter, single-arm, Phase 2 trial which
evaluates the efficacy and safety of sintilimab monotherapy in
subjects with relapse/refractory extranodal NK/T cell lymphoma
(nasal type) in China. Patients
will receive 200 mg sintilimab every 3 weeks until disease
progression. The study enrolled 28 patients. The primary endpoint
is objective response rate per LUGANO2014 criteria.
About Relapsed/Refractory (r/r) Extranodal NK/T Cell Lymphoma
(ENKTL)
Extranodal NK/T cell lymphoma is an aggressive malignancy and
accounts for more than 20% of the peripheral T-cell lymphoma in
Asia. Patients with relapse or
refractory disease have few treatment options and poor prognosis.
According to historical data, the overall survival is about 6
months, reflecting huge unmet medical needs.
About Tyvyt® (sintilimab injection)
Tyvyt® (sintilimab injection) is an innovative drug
jointly developed in China by
Innovent and Eli Lilly and Company. Innovent is also conducting
clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates
T-cells to kill cancer cells. Tyvyt® (sintilimab
injection) is the only PD-1 antibody in China branded by both a local
biopharmaceutical company and a global pharmaceutical company.
Tyvyt® (sintilimab injection) has been granted marketing
approval by the National Medical Products Administration (NMPA) for
relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and
has been included in the 2019 Guidelines of Chinese Society of
Clinical Oncology (CSCO) for Lymphoid Malignancies. There are
currently more than twenty clinical studies using sintilimab
injection, including eight registration studies that evaluate the
efficacy of sintilimab injection in other solid tumors.
About IBI305 (bevacizumab biosimilar)
IBI305 is a biosimilar product candidate of bevacizumab and a
recombinant humanized anti-VEGF monoclonal antibody for injection.
Vascular endothelial growth factor (VEGF) is an important factor in
angiogenesis that is highly expressed by the endothelial cells in
most human tumors. An anti-VEGF antibody binds VEGF selectively
with high affinity and blocks its binding to VEGF receptors on the
surface of vascular endothelial cells, thereby inhibiting signaling
pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab
produces anti-tumor effects by inhibiting the growth, proliferation
and migration of vascular endothelial cells, blocking angiogenesis,
reducing vascular permeability, blocking blood supply to tumor
tissues, inhibiting the proliferation and metastasis of tumor
cells and inducing apoptosis in tumor cells. The new drug
application (NDA) of IBI305 was accepted by the NMPA on
January 29, 2019 and has been
granted with priority review status.
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 oncology, autoimmunity 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 it was founded, Innovent has developed a fully-integrated
platform which includes R&D, CMC (Chemistry, Manufacturing, and
Controls), clinical development and commercialization capabilities.
Leveraging the platform, the company has built up a robust pipeline
of 20 innovative assets in the fields of oncology, ophthalmology,
autoimmunity, and cardiovascular diseases. Fourteen assets
have entered into clinical development, four have entered Phase 3
clinical trials, two monoclonal antibodies have their New Drug
Application (NDA) under review and have been granted with priority
review status, and one, Tyvyt® (sintilimab injection),
is now approved for relapsed or refractory classical Hodgkin's
lymphoma (r/r cHL).
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 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 collaboration with 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 will collaborate on 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. The
Innovent and Lilly partnership is one of the most comprehensive
strategic collaborations between a Chinese company and a
multinational partner in terms of the scope and breadth ranging
from discovery to commercialization and involving up to six
therapeutic antibodies for cancers.
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SOURCE Innovent Biologics, Inc.