Innovent Biologics and Lilly Announce Key Clinical Results of Sintilimab as Second-Line Therapy for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Suzhou, June 1, 2020 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic diseases, and Eli Lilly and Company (NYSE ticker symbol: LLY) jointly announced that the key clinical study results of sintilimab as second-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma (ORIENT-2), co-developed by both parties, were presented in a poster discussion at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract No. #4511, Poster No. #119, 8:00 AM – 11:00 AM U.S. Central Time, Friday, May 29, 2020).

The ORIENT-2 study presented at the ASCO Annual Meeting is a randomized, open-label, multicenter, Phase II controlled clinical trial comparing the efficacy and safety of sintilimab versus chemotherapy (paclitaxel or irinotecan) in patients with advanced/metastatic esophageal squamous cell carcinoma who have failed first-line therapy. A total of 190 subjects were enrolled and randomized in a 1:1 ratio to receive either sintilimab injection or chemotherapy (paclitaxel or irinotecan). The primary endpoint was overall survival (OS).

As of August 2, 2019, in the intent-to-treat (ITT) population, sintilimab significantly prolonged overall survival (OS) compared with paclitaxel/irinotecan (HR=0.70, P=0.032). The median OS was 7.2 months in the sintilimab group and 6.2 months in the chemotherapy group, with 12-month OS rates of 37.4% and 21.4%, respectively. Sintilimab demonstrated encouraging antitumor efficacy. The safety profile of sintilimab in esophageal squamous cell carcinoma was similar to that observed in other tumor types.

Professor Xu Jianming, Director of the Department of Gastrointestinal Oncology at the Fifth Medical Center of the Chinese PLA General Hospital, stated, “For patients with advanced/metastatic esophageal squamous cell carcinoma (ESCC) who have failed prior first-line therapy, treatment options are limited and clinical outcomes are poor. The results of the ORIENT-2 study demonstrated that sintilimab significantly prolonged overall survival and reduced the risk of death compared with paclitaxel or irinotecan in the second-line treatment of ESCC, with a hazard ratio of 0.70. Sintilimab can serve as an effective therapeutic agent for second-line treatment of ESCC, delivering greater clinical benefit to patients.”

About Tyvyt^®(Sintilimab Injection)

Tyvyt®^®(Sintilimab Injection) is an innovative, international-quality biologic drug jointly developed by Innovent Biologics and Eli Lilly and Company in China. Its first approved indication is for relapsed/refractory classical Hodgkin lymphoma, and it was included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma. During the 2019 National Reimbursement Drug List negotiations, Tyvyt^®(Sintilimab Injection) is the only PD-1 inhibitor included in the National Reimbursement Drug List.

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 Death-Ligand 1 (PD-L1) pathway that leads to tumor immune tolerance. This reactivates the anti-tumor activity of lymphocytes, achieving the goal of tumor treatment. Currently, more than 20 clinical studies (including over 10 registrational clinical trials) are underway to evaluate the anti-tumor effects of sintilimab in various solid tumors and hematologic malignancies. Innovent Bio is also conducting global clinical research on Sintilimab Injection.

About Innovent Bio

“Rooted in Trust, Realized through Action.” It is Innovent Bio’s vision and goal 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 medicines for the treatment of major diseases, including cancer, autoimmune disorders, and metabolic diseases. 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.

Since its establishment, the company has stood out among numerous biopharmaceutical companies with its innovative achievements and internationalized operating model. It has established a product pipeline comprising 23 new drug candidates, covering multiple therapeutic areas including oncology, autoimmune diseases, and metabolic disorders. Among these, six candidates were selected for the National “Major New Drug Development” Special Project, 17 have entered clinical studies, five have reached Phase III or pivotal clinical trials, and marketing applications for four monoclonal antibody products have been accepted by the NMPA, three of which were granted priority review. One product (Sintilimab Injection, brand name: Tyvyt^®, English trademark: TYVYT^®) received NMPA approval for marketing, with the first approved indication being relapsed/refractory classical Hodgkin lymphoma, and in November 2019, it became the only PD-1 inhibitor included in the new version of the National Reimbursement Drug List.

Innovent Bio has assembled a high-caliber team for the development and industrialization of biopharmaceuticals, featuring international advanced expertise and numerous overseas-returning experts. The company has established strategic collaborations with international partners including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical. Innovent Bio is committed to working collectively to elevate the development of China’s biopharmaceutical industry, thereby enhancing drug accessibility 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 more than a century ago, the company’s founder was committed to producing high-quality medicines to meet pressing medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop medicines that transform lives and deliver them to patients who need them most. 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。

Strategic Collaboration Between Innovent Bio and Eli Lilly

Eli Lilly and Innovent Bio entered into a biopharmaceutical 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, Eli Lilly and Innovent Bio will jointly develop and commercialize products in China, including Tyvyt^®Oncology drugs, including sintilimab injection. In October 2015, the two parties announced a further expansion of their established drug development collaboration by adding three novel oncology therapeutic antibodies. In August 2019, the collaboration was extended into the field of diabetes, with Innovent Bio licensed to develop and commercialize in China a potential global best-in-class novel clinical-stage diabetes drug from Eli Lilly. These three collaborations with Eli Lilly and Company mark that Innovent Bio has established a comprehensive strategic partnership between an innovative Chinese pharmaceutical enterprise and a global pharmaceutical giant, covering new drug research and development, clinical studies, manufacturing quality, and marketing and sales.