Innovent Biologics Inc, a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines, jointly announced with Eli Lilly and Company (Lilly) the research results of Tyvyt (sintilimab injection) ORIENT-1 study for the treatment of relapsed or refractory classic Hodgkin's lymphoma (r/r cHL), at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO).
The ORIENT-1 study is a multicenter, single-arm, phase 2 clinical trial, assessing the efficacy and safety of sintilimab in r/r cHL. Subjects received 200 mg of sintilimab every three weeks in this study until disease progression. A total of 96 subjects with r/r cHL were enrolled, and the study's primary endpoint was objective response rate (ORR) assessed by an independent imaging assessment committee (IRRC). In addition, the complete response (CR) rate was a secondary endpoint in the ORIENT-1 study.
As of the data cutoff on September 30, 2019, the ORR was 85.4% (82/96) based on IRRC review, of which 41 patients (42.7%) achieved complete response (CR).
Professor Yuan-kai Shi, Associate Dean from the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology said, "Treatment options for patients with r/r cHL remain limited, and new drugs with long-lasting efficacy and good safety are urgently needed. The results of long-term follow-up of the ORIENT-1 study showed that sintilimab can bring relatively more long-term benefits to r/r cHL patients."
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.