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 (oxaliplatin and capecitabine) for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
The sNDA application is based on the interim analysis of the randomized, double-blind, multi-center Phase 3 ORIENT-16 clinical trial – which evaluated sintilimab in combination with chemotherapy (oxaliplatin and capecitabine), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. 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, in both the intention-to-treat (ITT) group and PD-L1 positive group. The results of ORIENT-16 study were released in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.
The principal investigator of the ORIENT-16 study, Prof. Jianming Xu from the Fifth Medical Center of People's Liberation Army General Hospital, stated," We are very pleased to see that sintilimab in combination with chemotherapy can significantly improve the overall survival compared to chemotherapy alone, which met the predefined statistical superiority criteria. ORIENT-16 study was released in a late-breaking proffered oral presentation at the ESMO Congress 2021. This is the first double-blind, randomized controlled trial demonstrating that a PD-1 inhibitor plus chemotherapy significantly improved overall survival in the first-line treatment of advanced gastric cancer in China. In the past few decades, chemotherapy is the main treatment of advanced gastric cancer, and the overall survival continued to be less than 1 year. The data from the ORIENT-16 study highlights the potential for a new treatment option for patients with advanced gastric cancer.
Dr. Hui Zhou, Senior Vice President of Innovent, stated, "The treatment options for advanced gastric cancer are still very limited today. The ORIENT-16 study aims to address this unmet medical need. 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 advanced gastric cancer. 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 chemotherapy to Chinese patients with advanced gastric cancer."
About the ORIENT-16 Study
ORIENT-16 is a randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab or placebo, in combination with chemotherapy (oxaliplatin and capecitabine), for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ClinicalTrials.gov, NCT03745170). The primary endpoint was overall survival, in PD-L1 positive (CPS>5) and all randomized patients.
As of the cutoff date for the interim analysis, a total of 650 patients were enrolled and randomly assigned with a 1:1 ratio to receive sintilimab or placebo in combination with chemotherapy until disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. The study met both primary endpoints and 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 for the combination of sintilimab and chemotherapy. The results were published at the ESMO Congress 2021.
About Gastric Cancer
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