Innovent Biologics, Inc. announced the interim analysis results of ORIENT-16, the Phase 3 study evaluating sintilimab in combination with chemotherapy compared to chemotherapy for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma was published in The Journal of the American Medical Association (JAMA, IF=120.7). ORIENT-16 the first immunotherapy Phase 3 study published in JAMA for the first-line treatment the first-line treatment of gastric cancer, as well as the first immunotherapy Phase 3 in Chinese patients for the first- line treatment of gastric cancer. Gastric cancer is one of the most common malignant tumor types globally and nearly half of all cases are diagnosed in China.

OS benefits were consistent in all prespecified subgroup analyses. The overall safety profile of final analysis was consistent with that observed in previously reported interim analysis, and no additional safety signals were identified with additional 15-month follow-up. Bad on t the study results of ORIENT-16.

ORIENT-16, sintilIMab in combination with chemothera was approved by the National Medical Products Administration (NMPA) of China as first-line treatment for G/GEJ in June 2022, and was included in the national reimbursement drug list (NRDL), becoming the first and only immunotherapy for gastric cancer covered by NRDL in China. The principal investigator of the ORIENT-16 study, Prof. Jianming Xu from the Fifth Medical Center of People'sLiberation Army General Hospital, stated, "ORIENT-16 is the first phase 3 trial in China to demonstrate a significant overall survival benefit in patients with advanced G/GEJ cancer treated with anti-PD-1 antibody plus chemotherapy in first line setting. The study has met its primary endpoint in the prespecified interim result analysis, and its final analysis demonstrated the OS benefit of sintilimab plus chemotherapy in overall population and in patients with CPS =5 compared with chemotherapy alone.

ORIENT-16 is the first randomized controlled Phase 3 study in China to demonstrate that PD-1 in combination with chemotherapy significantly longs overall survival in overall population of first line treatment for G/GEJ adenocarcinoma. The publication in JAMA further confirms its huge clinical value of the ORIENT-16 Study ORIENT-16 is a randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilim AB in combination with chemotherapy, compared to placebo in combination with chemotherapy, for the first-line treatment.