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

On May 31, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines, reported 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 56th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Abstract # 4511, Poster # 119, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020) (Press release, Innovent Biologics, MAY 31, 2020, View Source [SID1234558750]).

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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.