Innovent Biologics and Lilly Jointly Announced the Pivotal Clinical Study Results of TYVYT(R) (Sintilimab Injection) in the Second-Line Treatment of Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

SUZHOU, China, June 1, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines, jointly announced with Eli Lilly and Company (Lilly) (NYSE: LLY) the results of TYVYT® (sintilimab injection) ORIENT-2 study, a pivotal clinical study of second-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) at the 56^th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract # 4511, Poster # 119, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).

The ORIENT-2 study was a randomized, open-label, multicenter, Phase 2 clinical study comparing the efficacy and safety of sintilimab with chemotherapy (paclitaxel or irinotecan) in patients with advanced or metastatic ESCC whose disease progressed on first-line therapy. A total of 190 subjects were enrolled in the study and randomly assigned in a 1:1 ratio to receive either sintilimab injection or chemotherapy (paclitaxel or irinotecan). The study's primary endpoint was overall survival (OS).

As of August 2, 2019, compared with paclitaxel/irinotecan, sintilimab demonstrated a statistically significant improvement in OS in the intent-to-treat (ITT) population (HR = 0.70, P = 0.032). The median OS in the sintilimab-treated group and the chemotherapy-treated group were 7.2 months and 6.2 months and the 12-month OS rates were 37.4% and 21.4%, respectively, showing encouraging antitumor efficacy in the sintilimab-treated group. The safety profile of sintilimab in this study of ESCC patients was similar to that seen in studies of sintilimab in other tumors.

Professor Jianming Xu, Director of the Department of Gastrointestinal Oncology at the Fifth Medical Center of PLA General Hospital, said: "For patients with advanced or metastatic ESCC who have progressed on first-line treatment, there are few next treatment options and traditional chemotherapy drugs have shown a very limited effect. The ORIENT-2 study confirmed that sintilimab can prolong OS compared with chemotherapy (paclitaxel or irinotecan) in the second-line treatment of patients with ESCC. We are hopeful that sintilimab can be used as an effective treatment option for the second-line treatment of ESCC, bringing more clinical benefits to patients in need."

About TYVYT^® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019. 

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-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture 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, autoimmune, metabolic 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 multifunctional 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 oncology, autoimmune, metabolic diseases and other major therapeutic areas, with 17 in clinical development, five in Phase 3 or pivotal clinical trials, four under NDA reviews by the NMPA (three under priority review status), while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL, since 2019.

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, MD Anderson Cancer Center, Hanmi and other international partners. 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 create medicines that 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 Biologics' 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. 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 fields such as R&D, CMC, clinical development and commercialization.

SOURCE Innovent Biologics, Inc.