Pharma Focus Asia

Innovent Biologics and Lilly Jointly Announced the Long-Term Follow-Up Results of TYVYT

Monday, June 01, 2020

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines, jointly announced with Eli Lilly and Company (Lilly) (NYSE: LLY) 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) (Abstract # 8034, Poster # 367, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).

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."

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