Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) for the first-line treatment of esophageal squamous cell carcinoma (ESCC).
The sNDA application is based on the interim analysis of the global randomized, double-blind, multi-center Phase 3 ORIENT-15 clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy, regardless of PD-L1 expression status. The results of ORIENT-15 were presented at the European Society for Medical Oncology (ESMO) Congress 2021 on September 17.
The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute, stated," Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, and squamous cell carcinoma is the predominant histologic type. In China, cisplatin plus paclitaxel is widely used to treat patients with ESCC. The results of ORIENT-15 demonstrated that sintilimab plus chemotherapy significantly improved overall survival and progression-free survival compared to chemotherapy. These results suggest that this sintilimab regimen could be a suitable treatment option for ESCC patients in China."
Dr. Hui Zhou, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for advanced or metastatic ESCC. The acceptance of this sNDA by the NMPA represents an important milestone in demonstrating the potential value of sintilimab in the first-line treatment of ESCC. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring the new regimen of sintilimab plus cisplatin and paclitaxel to Chinese patients with ESCC as quickly as possible."
About the ORIENT-15 Study
ORIENT-15 is a global randomized, double-blind, multicenter 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 (of the planned 676 estimated participants) were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. The primary endpoints were overall survival (OS) in all randomized patients and OS in PD-L1 positive (defined as CPS ≥10) patients.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer (EC) is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease worldwide each year. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. More than half of new and fatal cases of esophageal cancer in the world occur in China. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, where it has a five-year survival rate of only 30%. In the US, it is estimated there were approximately 18,000 new c...
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