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 announced that the Phase 3 ORIENT-15 study met the predefined overall survival primary endpoint. ORIENT-15 is a global randomized, double-blind, multi-center clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified. These results will be presented at an upcoming medical meeting.
The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute stated, "More than half of new and fatal cases of esophageal cancer in the world occur in China every year. In China, esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer, and squamous cell carcinoma (ESCC) is the predominant histologic type. Treatment options for people with ESCC are limited. Chemotherapy is currently the main treatment for ESCC and, in recent years, immunotherapy has brought new hope in the treatment of this type of cancer, with some PD-1 inhibitors receiving approval as a second-line treatment for patients with ESCC in China. We are encouraged by these interim results of the ORIENT-15 study which demonstrated that sintilimab in combination with chemotherapy prolonged overall survival in the first-line treatment of patients with ESCC, regardless of PD-L1 status."
Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "The treatment options for locally advanced or metastatic ESCC are limited and represent a significant unmet clinical need. ORIENT-15 is the largest clinical study of sintilimab conducted by Innovent to date. Despite the COVID-19 pandemic, the joint effort of the study's investigators and broader team have enabled us to reach this milestone. We would like to express our sincere gratitude to all the patients who participated in the ORIENT-15 study. We hope these results can help to provide a new treatment option for patients with ESCC."
About the ORIENT-15 Study
ORIENT-15 is a global randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. Patients were enrolled regardless of PD-L1 status. The primary endpoints included overall survival in all randomized patients and overall survival in PD-L1 positive (defined as CPS ≥10) patients.
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