On May 31, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported the two-year follow-up results of TYVYT (sintilimab injection) ORIENT-4 study in relapsed or refractory Extranodal NK/T-cell lymphoma (nasal type) at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Abstract # 8050, Poster # 383, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020) (Press release, Innovent Biologics, MAY 31, 2020, View Source [SID1234558752]).
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ORIENT-4 is a multicenter, single-arm, Phase 2 clinical study evaluating the efficacy and safety of sintilimab in relapsed or refractory extranodal NK/T-cell lymphoma (nasal type). A total of 28 subjects were enrolled in the study, all of whom received sintilimab injection (200 mg, IV, Q3W). The study’s primary endpoint was objective response rate (ORR) based on Lugano 2014 response evaluation criteria.
As of January 17, 2020, the ORR was 67.9% and the complete response (CR) rate was 14.3%. The disease control rate (DCR) was 85.7% and the median overall survival (OS) had not been reached, which was 78.6% at two years, with no new safety signals identified.
Professor Jianyong Li, Director of Hematology Department at Jiangsu Provincial People’s Hospital, said "For patients with extranodal NK/T-cell lymphoma (nasal type) that do not respond to a L-asparaginase-containing regimen, there is no internationally recommended treatment regimen, resulting in an urgent clinical need to find effective therapeutic drugs to treat this disease. The results of the ORIENT-4 study showed that the ORR based on Lugano 2014 efficacy evaluation criteria was as high as 67.9% and the two-year OS rate was 78.6%. Sintilimab was statistically demonstrated the significant clinical efficacy in the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (nasal type), and could bring long-term benefits to patients."
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.