Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced the results of a Phase 3, open label, randomized study in China. The ORIENT-32 trial evaluating TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection, or IBI305) as a first-line treatment in advanced hepatocellular carcinoma (HCC) met the predefined primary endpoints of progression-free survival (PFS) and overall survival (OS) in an interim analysis. This is the first Phase 3 clinical trial using PD-1 inhibitor-based combination therapy that has met the primary endpoint in the first-line treatment of advanced HCC.
Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) demonstrated a statistically significant improvement in PFS and OS compared with sorafenib. The safety profile of TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab biosimilar injection) in this trial was consistent with previously reported studies, and no new safety signals were identified. These data will be presented at an upcoming medical conference. Based on the IDMC recommendation, Innovent will review these results with the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.
The principal investigator of the ORIENT-32 study, Professor Fan Jia from Zhongshan Hospital of Fudan University, stated: "In China, HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year. At present, sorafenib, lenvatinib and chemotherapy are the main treatments for HCC in the first-line treatment setting in China, with very limited efficacy. About 85% of HCC patients in China have the history of HBV infection, which is a quite different feature from HCC in the European and American countries. Therefore, continued clinical research in treating HCC is of great importance in China. The ORIENT-32 study confirmed that TYVYT® (sintilimab injection), in combination with BYVASDA® (bevacizumab biosimilar injection), can prolong PFS and OS in the first-line treatment of HCC. Despite the COVID-19 pandemic, all study investigators worked to overcome many challenges to continue this trial with the goal of bringing new hope to HCC patients."
Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent stated: "TYVYT® is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List in China. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy. BYVASDA® (bevacizumab biosimilar injection) was officially approved by the NMPA for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. The results of the ORIENT-32 study demonstrate the potential of TYVYT® in combination with BYVASDA® to treat patients with advanced HCC in the first-line setting. We hope this clinical trial can potentially provide a more effective treatment option for clinicians and HCC patients. We would like to express our sincere gratitude to all the patients and investigators who participated in the ORIENT-32 study. Outstanding contributions were made through the joint efforts of investigators and the study team, despite the challenges and impact from the COVID-19 pandemic.
About ORIENT-32 Trial
ORIENT-32 is a Phase 3 randomized, open-label, multi-center study to evaluate the efficacy and safety of TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT 03794440). The primary endpoints are progression-free survival (PFS) and overall survival (OS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.
Enrolled patients were randomly assigned 2:1 to receive TYVYT® (sintilimab injection) combination with BYVASDA® (bevacizumab biosimilar i...
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