SUZHOU, China, May 16, 2018 /PRNewswire/ -- Innovent
Biologics (Suzhou) Co. Ltd. (Innovent Biologics) today announced
the findings from the ORIENT-1 trial investigating Sintilimab, the
company's fully human anti-PD-1 therapy (IBI308), in patients with
relapsed/refractory classical Hodgkin Lymphoma (r/r cHL). The
preliminary result of the ORIENT-1 trial was published at ASCO's
official website on May 16,
2018. The updated and final analysis on its primary endpoint
mentioned in this press release will be presented at the 2018 ASCO
Annual Meeting in Chicago in a
poster session on Saturday, June 4,
2018.
ORIENT-1 is a multicenter, single-arm, phase 2 registrational
study assessing the efficacy and safety profile of IBI308. A
total of ninety-six patients with r/r cHL were enrolled. It is
the largest study for this indication in China.
The primary endpoint is objective response rate (ORR), defined
as the percentage of study subjects who either experienced a
partial response (PR) or a complete response (CR), which was
assessed by independent radiographic review committee (IRRC)
according to the revised international working group response
criteria for malignant lymphoma in 2007 (IWG 2007). Complete
response rate (CR) is a secondary endpoint.
Based on the assessment by IRRC, among the 96 patients with a
minimum 24-week follow-up, the results showed an overall response
rate (ORR) of 79.2%, disease control rate (DCR) of 97.9%, meeting
the pre-set statistical criteria. The median duration of
response has not been reached and the majority of the patients are
continuing to respond to therapy. The study did not reveal any
unexpected safety issues and there is no death reported. The
safety profile of Sintilimab is similar to what have been reported
in connection with other anti-PD-1 antibody products
developed.
The new drug application (NDA) for IBI308 for the treatment of
r/r cHL was officially accepted by the Center of Drug Evaluation of
the China Food and Drug Administration (CFDA) on April 19, 2018 and was granted the "Priority
Review Status" on April 23, 2018.
"Sintilimab, jointly developed by Innovent Biologics and Eli
Lilly and Company, is a novel anti-PD-1 antibody with global IP
rights. I am very grateful for my colleagues at Innovent
Biologics, various government agencies and our partner Lilly for
their effort and dedication." said Dr. Michael Yu, the founder and CEO of Innovent
Biologics. "Sintilimab will bring new hope for patients with
relapsed and refractory classical Hodgkin Lymphoma in
China. Our mission is to develop and commercialize high
quality biopharmaceutical products that are affordable to ordinary
people. Now we have just completed the very first critical
step toward that mission."
"We are very pleased with the Lilly/Innovent research and
development collaboration. Together, we are making progress toward
our shared goal of bringing innovative medicines to
China. We firmly believe that
our in-depth collaboration with Innovent may bring medical
advances that eventually benefit many cancer patients throughout
China," said Levi Garraway, M.D., Ph.D., senior vice
president, global development and medical affairs, Lilly
Oncology.
About Sintilimab
Sintilimab is a fully human anti-PD-1 antibody. It binds
to the PD-1 receptor on T cells, blocking the PD-L1 ligand from
interacting with PD-1 to help restore T-cell response and immune
response, thus destroying the tumor cells. Sintilimab is
jointly developed by Innovent Biologics and Eli Lilly and Company
in China. It is also the
first drug submitted for NDA by Innovent Biologics.
About ORIENT-1 Trial
ORIENT-1 (NCT03114683) is a multicenter, single-arm, phase 2
registrational study assessing the efficacy and safety profile of
IBI308. A total ninety-six patients with r/r cHL were
enrolled. It is the largest study for this indication in
China.
The primary endpoint is objective response rate (ORR), defined
as the percentage of study subjects who either experienced a
partial response (PR) or a complete response (CR), which was
assessed by independent radiographic review committee (IRRC)
according to the revised international working group response
criteria for malignant lymphoma in 2007 (IWG 2007). Complete
response rate (CR) is a secondary endpoint.
The study requires that the assessment of CR can only be
performed by PET at week 15. Therefore, the CR data only
represents a single point assessment at week 15.
About Relapsed/Refractory classical Hodgkin Lymphoma (r/r
cHL)
Hodgkin Lymphoma is a relatively rare B cell malignancy, often
seen in population aged between 20 and 40, and most of the patients
are classic in terms of pathology subgroup. Although the
current treatment for HL is very efficacious with high cure rate,
about 20% of them will relapse after initial treatment due to
treatment failure or intolerance to drug treatment. How to
treat r/r cHL effectively is a serious challenge among oncology and
hematology community. The average survival is only 1-2 years
once a patient relapses after autologous hematopoietic stem cell
transplantation (HSCT).
About Innovent Biologics
Innovent Biologics, a leading biopharmaceutical company in
China, was established in
2011. Its core business is to develop and commercialize
therapeutic antibodies for complex and debilitating
diseases. As of today, Innovent Biologics has established a
pipeline composed of 16 monoclonal antibody products, covering four
major disease areas: oncology, ophthalmology, autoimmune diseases,
and cardiovascular diseases. Seven candidates are in clinical
stage, four of them are in phase 3 clinical trials and Sintilimab
has been accepted for NDA by CFDA with a designation of priority
review. In addition, Innovent Biologics designs and builds
its manufacturing facilities in accordance with the GMP standards
of the CFDA, FDA and EMA. Three production lines have passed
the audits conducted by a global biopharmaceutical company in
accordance with its global standards.
Innovent Biologics has attracted private financing from a number
of world-renowned VC firms, including Fidelity, Lilly Asia Venture, Capital Group, Legend
Capital, Temasek, SDIC, China Life, and Hillhouse Capital and has
established a deep strategic partnership with Eli Lilly.
Inspired by its corporate spirit of "Start with Integrity,
Succeed by Action," Innovent Biologics' mission is to develop and
commercialize high quality biopharmaceutical products that are
affordable to ordinary people.
About the partnership between Innovent Biologics and
Lilly
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 shall collaborate to provide support to 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 which has already been one of the largest
collaboration in China between a
multi-national and domestic biopharmaceutical company. These
collaborations represent that Innovent has struck one of the most
comprehensive strategic partnerships of any Chinese company with a
multinational partner in terms of the scope and breadth ranging
from discovery to commercialization and involving up to six
therapeutic antibodies for cancers.
For inquiries, please contact:
Innovent Biologics, Inc.
Email: ir@innoventbio.com
Tel: 86 512 6956 6088
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