Innovent Announces the Phase 3 ORIENT-16 Study Results Published in JAMA Evaluating Sintilimab in Combination with Chemotherapy for the First-Line Treatment of Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

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ROCKVILLE, Md. and SUZHOU, China, Dec. 5, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, 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 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[i]. Advanced gastric cancer generally has very poor prognosis with high unmet medical need. ORIENT-16 demonstrated that sintilimab plus chemotherapy significantly prolongs overall survival in the first line treatment for overall population of gastric cancer. Based on the results of ORIENT-16, sintilimab is recommended by the Chinese Society of Clinical Oncology (CSCO) guidelines for the first-line treatment of gastric cancer. It is also the first and only PD-1 inhibitor included in national reimbursement drug list (NRDL) for the first-line treatment of gastric cancer.

ORIENT-16 has met its primary endpoint at the prespecified interim analysis. Sintilimab in combination with chemotherapy demonstrated superior and clinical meaningful overall survival (OS) benefit, compared with placebo plus chemotherapy in all randomized patients as well as patients with CPS ≥5 . Detailed interim analysis results were published in JAMA.

  • Interim analysis (cut-off date June 20, 2021, median follow-up 18.8 month) showed that, sintilimab in combination with chemotherapy significantly reduced the risk of death in all randomized patients (HR 0.77, 95%CI 0.63-0.94, p=0.009) and in patients with CPS ≥5 (HR 0.66, 95%CI 0.50-0.86, p=0.002) , successfully reached the prespecified superiority criteria. Median overall survival (mOS) has been prolonged by 2.9months (mOS 15.2mo vs. 12.3mo) in all randomized patients, and 5.5 months (mOS 18.4mo vs. 12.9mo) in patients with CPS ≥5, respectively. In addition, OS benefits were consistent in all prespecified subgroups. 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 in GC patients.

Furthermore, prespecified final analysis results of ORIENT-16 has been published at the AACR (American Association for Cancer Research) Annual Meeting. Final analysis (with additional 15-month follow-up) indicated that OS benefits of sintilimab plus chemotherapy have become more evident in overall population and in patients with CPS ≥5 compared with that of interim analysis, further confirming sintilimab plus chemotherapy as a standard of care of 1L treatment for G/GEJ adenocarcinoma.

  • Final analysis (cut-off date September 2, 2022, median follow-up 33.9 mo) showed that, sintilimab in combination with chemotherapy significantly reduced the risk of death in all randomized patients (HR 0.68, 95% CI: 0.57-0.81; P

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