Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the first patient has been successfully enrolled and dosed in the randomized, open-label, phase III, multicenter clinical study (NCT04720716) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the first-line treatment of patient with advanced hepatocellular carcinoma (HCC).
In recent years, immune checkpoint inhibitors have brought new hope to HCC patient population with acceptable safety and encouraging efficacy. NCT04720716 is a randomized, open-label, controlled, multicenter phase III study evaluating the efficacy and safety of IBI310 in combination with TYVYT® (sintilimab injection) for advanced HCC patients. Primary endpoints include overall survival and objective response rate. The study was led by Professor Fan Jia from Zhongshan Hospital of Fudan University, and Professor Qin Shukui from Affiliated Jinling Hospital, Medical School of Nanjing University. This study involves more than 50 clinical centers.
Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. IBI310 in combination with TYVYT® (sintilimab injection) has shown promising preliminary good safety and anti-tumor activity, suggesting the potential anti-tumor value for this combination. We will evaluate the efficacy of IBI310 combined with TYVYT® (sintilimab injection) in this study and we hope to provide more effective treatment to benefit patients and their families."
About IBI310
IBI310 is a recombinant fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). IBI310 can interfere with the binding of CTLA-4 and CD80/CD86 on antigen presenting cells, thereby blocking the inhibitory effect on T cell activation. IBI310 can promote the activation and amplification of T cells, and enhance the anti-tumor ability of the immune system.
CTLA-4 provides a new approach for immunotherapy in many diseases, including tumors. Innovent has announced the preliminary results of the Phase 1 clinical study about anti-CTLA-4 monoclonal antibody (NCT03545971) at the 56th Annual American Society of Clinical Oncology (ASCO) (Online Publication, Abstract No. 302489). Phase II/III clinical studies of IBI310 combined with TYVYT® (sintilimab injection) for multiple tumors are ongoing.
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. In December 2018, TYVYT® (sintilimab injection) was first approved by the China NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy. In February 2021, TYVYT® (sintilimab injection) was approved by the China NMPA in combination with pemetrexed and platinum chemotherapy as first-line therapy for the treatment of nonsquamous non-small cell lung cancer. TYVYT® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.
Currently TYVYT® (sintilimab injection) has three supplemental New Drug Applications ("sNDA") under review by the NMPA. In August 2020, the NMPA accepted sNDA for TYVYT® (sintilimab injection) in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In January 2021, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab injection) as first-line therapy in Hepatocellular Carcinoma (HCC) and the sNDA for TYVYT® (sintilimab injection) as second-line therapy in squamous NSCLC. Besides, in May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carc...
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