Innovent Biologics Presents Extended Follow-up Data of Sintilimab in Relapsed or Refractory Classical Hodgkin Lymphoma at ASCO 2019

Suzhou, June 4, 2019 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as cancer and autoimmune disorders, announced today that new extended follow-up data from the ORIENT-1 study on sintilimab, co-developed with Eli Lilly and Company, for the treatment of relapsed or refractory classical Hodgkin's lymphoma, were presented in poster format (Poster No. #7533) at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).，U.S. Central Time, June 3 (Monday), 8:00 AM – 11:00 AM

The American Society of Clinical Oncology (ASCO) Annual Meeting is one of the largest, most prestigious, and authoritative international academic conferences in the field of oncology. The 2019 ASCO Annual Meeting, themed “Caring for Every Patient, Learning from Every Patient,” brought together tens of thousands of world-renowned oncology experts, scholars, regulatory officials involved in drug approval, and patient advocacy organizations, launching a grand forum dedicated to the presentation and exchange of clinical oncology research findings.

Notably, an increasing number of Chinese pharmaceutical companies are making their presence felt on this international stage, amplifying the “Chinese voice” at international oncology conferences. At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, Innovent Bio will present key results from multiple clinical studies, including those on sintilimab for the treatment of relapsed/refractory extranodal NK/T-cell lymphoma.To be manufacturedIn addition to the oral presentation,TheAdditional key study results were presented at the 2019 ASCO Annual Meeting via posters and other formats.

The ORIENT-1 study, led by Professor Shi Yuankai, Vice President of the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Medical Oncology, is a multicenter, single-arm, Phase II study evaluating the efficacy and safety of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL). A total of 96 patients with r/r cHL were enrolled, representing the largest patient cohort in China to date.MaximumStudy on Relapsed or Refractory cHL.

The primary clinical endpoint of this study was the objective response rate (ORR), defined as the proportion of subjects whose best overall tumor response was either partial response or complete response, assessed according to the 2007 Revised Response Criteria for Malignant Lymphoma (IWG 2007) as the primary efficacy evaluation standard, and evaluated by an Independent Central Radiology Review Committee (IRRC). Additionally，Complete Response Rate (CRR) was a secondary endpoint in the ORIENT-1 study.

As of October 16, 2018, with a median follow-up duration of 14 months, 72.9% of patients were still receiving treatment. Assessed by the Independent Central Imaging Review Committee, the objective response rate (ORR) was 85.4% (82/96; 95% CI: 76.7–91.8). Twenty-eight patients (29.2%) achieved confirmed complete response (CR) as determined by PET-CT. The median duration of response (DOR) and median progression-free survival (PFS) had not been reached. The drug demonstrated favorable tolerability and safety profiles.

Based on this pivotal study, sintilimab was approved for marketing in China for the treatment of relapsed or refractory classical Hodgkin lymphoma.

The updated data with extended follow-up presented at the 2019 ASCO Annual Meeting revealed that the primary endpoint, overall response rate (ORR), reached 85.4%, and the secondary endpoint, complete response (CR) confirmed by PET-CT, also reached 29.2%. Innovent Bio will continue to update response and survival data for patients treated with sintilimab in this clinical trial.

About Tyvyt® (Sintilimab Injection)

Tyvyt^®(Sintilimab Injection) is an innovative biologic of international quality jointly developed by Innovent Bio and Eli Lilly in China. Innovent Bio is currently conducting clinical research on Sintilimab Injection in the United States. Tyvyt^®(Sintilimab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/Programmed Cell Death-1 Ligand-1 (PD-L1) pathway that leads to tumor immune tolerance, reactivating the anti-tumor activity of lymphocytes, and thus achieving the purpose of treating tumors. Tyvyt^®(Sintilimab Injection) is a Chinese innovative PD-1 inhibitor of international quality. Its marketing application has been officially approved by the National Medical Products Administration (NMPA), with the first approved indication being relapsed/refractory classical Hodgkin lymphoma. It has also been included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma. Currently, more than twenty clinical studies (including eight registration trials) are underway to investigate the antitumor effects of sintilimab in other solid tumors.

About Innovent Bio

“Built on Trust, Delivered through Action.” Innovent Bio’s vision and goal is to develop high-quality biologics that are affordable for the general public. Founded in 2011, Innovent Bio is dedicated to the development, manufacturing, and sales of innovative drugs for the treatment of major diseases such as cancer. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 01801.

Currently, the company has established a high-quality technical platform that covers the entire lifecycle of biological innovative drug development, including R&D, pharmaceutical development and industrialization, clinical research, and marketing. It has built a product pipeline comprising 20 new drug candidates in development, covering four major therapeutic areas: oncology, fundus diseases, autoimmune diseases, and metabolic disorders. Fourteen candidates have entered clinical trials, with four in Phase III clinical studies. Marketing authorization applications for two monoclonal antibody products have been accepted by the National Medical Products Administration (NMPA) and included in the priority review program. One product (Sintilimab Injection, brand name: Tyvyt®) has been approved for marketing by the NMPA. The approvedFirstIndication: Relapsed/Refractory Classical Hodgkin Lymphoma.

Innovent Bio has assembled a world-class team of experts in the development and industrialization of high-end biologics, including numerous overseas-returning specialists, and has established strategic collaborations with international pharmaceutical companies such as Eli Lilly and Company, Adimab, Incyte, and Hanmi Pharmaceutical. Innovent Bio is committed to working collaboratively to advance the development of China’s biopharmaceutical industry, thereby improving access to medicines for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company’s website:www.innoventbio.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Founded over a century ago, the company’s founder was committed to producing high-quality medicines to meet tangible medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop life-changing medicines and deliver them to patients who genuinely need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through charitable initiatives and volunteer activities. For more information about Eli Lilly and Company, please visit:www.lilly.com。 

On the Strategic Cooperation Between Innovent Bio and Eli Lilly

Innovent Biologics (Innovent) and Eli Lilly reached a biologic drug development collaboration in March 2015, which remains one of the largest partnerships to date between a Chinese biopharmaceutical company and a multinational pharmaceutical corporation. Under the terms of the agreement, Innovent and Eli Lilly will jointly develop and commercialize at least three oncology therapeutic antibodies over the following decade. In October 2015, the two parties announced a further expansion of their established drug development collaboration, adding three novel oncology therapeutic antibodies. These two collaborations with Eli Lilly signify that Innovent has established a comprehensive strategic partnership between an innovative Chinese pharmaceutical enterprise and a global pharmaceutical giant, encompassing new drug research and development, manufacturing quality, and market commercialization.