Innovent Biologics Announces ORIENT-15 Phase III Trial of Sintilimab Plus Chemotherapy Met Primary Endpoints in First-Line Treatment of Esophageal Squamous Cell Carcinoma

SAN FRANCISCO and SUZHOU, China, June 23, 2021 /PRNewswire/ -- Innovent Biologics (HKEX: 01801), a biopharmaceutical company committed to the research, development, production, and commercialization of innovative medicines for the treatment of major diseases such as cancer, metabolic diseases, and autoimmune diseases, today announced that the interim analysis of ORIENT-15, a randomized, double-blind, international, multicenter Phase III clinical study evaluating the innovative PD-1 inhibitor sintilimab (co-developed by Innovent and Eli Lilly) in combination with chemotherapy (cisplatin + paclitaxel / cisplatin + 5-fluorouracil) as first-line treatment for advanced or metastatic esophageal squamous cell carcinoma, has met its primary endpoint.

Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC),Regardless of PD-L1 expression status, sintilimab plus chemotherapy significantly prolonged overall survival (OS) in patients compared with placebo plus chemotherapy,The pre-specified superiority criteria were met. The safety profile was consistent with previously reported clinical data for sintilimab, with no new safety signals identified. Relevant study results will be presented at upcoming international academic conferences.

Professor Shen Lin, Principal Investigator of the ORIENT-15 study and Vice President of Peking University Cancer Hospital, stated: “The ORIENT-15 study is an international multicenter trial on the first-line treatment of esophageal squamous cell carcinoma (ESCC) led by Chinese researchers. Globally, more than half of new esophageal cancer cases and deaths occur in China. In China, esophageal cancer ranks fifth in incidence and fourth in mortality among malignancies, with squamous cell carcinoma being the predominant histological subtype. Conventional chemotherapy and radiotherapy remain the mainstay of treatment for advanced or metastatic ESCC; however, the prognosis remains poor due to a lack of more effective therapeutic options. In recent years, immune checkpoint inhibitors have brought new hope to the treatment of esophageal cancer, and PD-1 monoclonal antibodies have been approved in China and internationally for the second-line treatment of ESCC. Today, we are greatly encouraged to see that the ORIENT-15 results confirm that sintilimab in combination with chemotherapy significantly prolongs overall survival in patients receiving first-line treatment for ESCC, which will bring new hope to a vast number of ESCC patients.”

Dr. Zhou Hui, Senior Vice President of Clinical Development at Innovent Biologics Group, stated: "Treatment options for advanced or metastatic esophageal squamous cell carcinoma are highly limited, representing a significant unmet clinical need. The ORIENT-15 study is the largest clinical trial conducted by Innovent to date, carried out amidst the global COVID-19 pandemic. Thanks to the tireless efforts of all investigators and the project team, we have achieved exciting and robust study results. We also extend our sincere gratitude to every participant who enrolled in this trial. We hope to make the sintilimab plus chemotherapy regimen available to ESCC patients as early as possible, thereby benefiting more patients and their families."