Innovent Provides Updates on Extended Follow-up on Sintilimab for Relapsed/Refractory Classical Hodgkin's Lymphoma

SUZHOU, China, June 4, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the results of extended follow-up on sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, for relapsed/refractory classical Hodgkin's lymphoma (r/r cHL) (ORIENT-1) were presented by poster at the 55th annual meeting of the American Society of Clinical Oncology (ASCO) [Abstract #7533; Monday, June 3, 8:00 AM -11:00 AM CDT].

As the top and most influential international oncology conference, ASCO Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient," 2019 ASCO Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO, showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from several other clinical studies will be presented by posters and other sessions.

ORIENT-1, led by Professor Yuan-kai Shi, Associate Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology, is a multicenter, single-arm, Phase II study in China, evaluating the efficacy and safety of sintilimab for the treatment of patients with relapsed/refractory classical Hodgkin's lymphoma. Currently, ORIENT-1 study has the largest cohort of cHL patients in China with a total of 96 patients involved.

The primary clinical endpoint is objective response rate (ORR) as assessed by an independent radiological review committee (IRRC) according to 2007 IWG criteria. Moreover, complete response rate (CRR) is a secondary endpoint.

As of the data cutoff on 16 Oct 2018, 72.9% of patients were continuing treatment with a median follow-up of 14 months. ORR was 85.4% (82/96, 95% CI: 76.7 - 91.8) based on IRRC review. Twenty-eight patients (29.2%) achieved complete response (CR) by PET scan. The median duration of response (DoR) and progression free survival (PFS) have not been reached. Sintilimab showed an acceptable safety profile during the study.

Based on the results of ORIENT-1 study, sintilimab was approved for treating patients with r/r cHL in China.

The extended follow-up shows that the primary endpoint, ORR, has increased to 85.4% and the secondary endpoint, CR by PET scan, has increased to 29.2 %. Innovent intends to continue updating the response and survival rate for patients who have received sintilimab in this clinical trial.

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 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 III 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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