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Innovent Announces Results Of TYVYT In Treatment Of Locally Advanced Or Metastatic ESCC

Innovent Biologics Inc. and Eli Lilly and Co. (LLY) announced the results of TYVYT or sintilimab injection ORIENT-2 study, a pivotal clinical study of second-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma or ESCC.

The ORIENT-2 study was a randomized, open-label, multicenter, Phase 2 clinical study comparing the efficacy and safety of sintilimab with chemotherapy (paclitaxel or irinotecan) in patients with advanced or metastatic ESCC whose disease progressed on first-line therapy.

Sintilimab demonstrated a statistically significant improvement in overall survival in the intent-to-treat (ITT) population, as of August 2, 2019, compared with paclitaxel/irinotecan.

The median OS in the sintilimab-treated group and the chemotherapy-treated group were 7.2 months and 6.2 months and the 12-month OS rates were 37.4% and 21.4%, respectively, showing encouraging antitumor efficacy in the sintilimab-treated group. The safety profile of sintilimab in this study of ESCC patients was similar to that seen in studies of sintilimab in other tumors.

Separately, Innovent Biologics and Eli Lilly announced the research results of TYVYT or sintilimab injection ORIENT-1 study for the treatment of relapsed or refractory classic Hodgkin's lymphoma.

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.

As of the data cutoff on September 30, 2019, the objective response rate was 85.4% based on IRRC review, of which 41 patients (42.7%) achieved complete response.

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