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, today announces that the first patient has been successfully enrolled and dosed in the randomized, double-blind, phase 2 multi-center clinical trial (NCT04590599) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer.
The trial is a randomized, double-blind, controlled, parallel cohort phase 2 clinical trial evaluating the efficacy and safety of IBI310 versus placebo, in combination with TYVYT® (sintilimab injection), for advanced cervical cancer patients who have failed first and later line or intolerant of platinum-based chemotherapy. This clinical trial plans to enroll 174 patients with advanced cervical cancer.
Primary Investigator of the study, Professor Ding Ma of Tongji Hospital affiliated to Huazhong University of Science and Technology, stated:" Cervical cancer is the 4th most common malignant tumor among women in the world. in China, it ranks the 6th highest incidence rate (154/100,000) and 8th highest mortality rate (69/100,000) across tumor types. Treatment option of advanced cervical cancer is limited. The five-year survival rate of Stage IVb cervical cancer is still at a low level of less than 17%. Currently there is no standard treatment for patients with advanced cervical cancer who have failed platinum-based chemotherapy, representing a huge unmet clinical need. In recent years, immune checkpoint inhibitors have brought new hope to such patient population. We hope to explore the therapeutic value of the regimen of IBI310 in combination with TYVYT® (sintilimab injection) as second-line or above treatment for patients with advanced cervical cancer."
Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted. So far there is no CTLA-4 targeted drug approved in China. With the most advanced progress in clinical development in China, IBI310 in combination with TYVYT® (sintilimab injection) has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with TYVYT® (sintilimab injection) in the phase II trial 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 trial 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), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of 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 included in the new C...
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