Innovent Biologics, Inc., 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 approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (HCC). This is the first regulatory approval of a PD-1 inhibitor-based combination therapy for the first-line treatment for HCC.
This is also the fourth NMPA-approved indication of TYVYT® (sintilimab injection) as well as the fourth NMPA-approved indication of BYVASDA® (bevacizumab biosimilar injection). TYVYT® (sintilimab injection) was approved in China for the treatment of relapsed or refractory classical Hodgkin's lymphoma in December 2018, the first-line treatment of nonsquamous non-small cell lung cancer (NSCLC) in February 2021, and the first-line treatment of squamous NSCLC in June 2021. BYVASDA® (bevacizumab biosimilar injection) was previously approved for advanced non-small cell lung cancer, metastatic colorectal cancer, and adult recurrent glioblastoma.
This new approval was based on the results of a randomized, open-label Phase 3 clinical trial (ORIENT-32) of TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as first-line therapy for unresectable 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 overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) compared to sorafenib, meeting the pre-defined efficacy criteria. Safety analyses revealed no new safety signals. The ORIENT-32 results were published in The Lancet Oncology on June 15, 2021.
Professor Fan Jia from Zhongshan Hospital of Fudan University stated," In China, liver cancer is the second most common cause of cancer-related death and ranks fourth in terms of incidence with a five-year survival rate of only 10 percent. Response of hepatocellular carcinoma to chemotherapy and targeted therapy is undesirable, while immunotherapy has emerged as breakthrough treatment for hepatocellular carcinoma. The ORIENT-32 has demonstrated that sintilimab plus bevacizumab can extend the overall survival and progression-free survival in this patient population and bring significant clinical benefits. The approval will provide a new option for the first-line treatment of these patients with few systemic options, and also contribute to the 'Healthy China 2030'."
Dr. Yongjun Liu, President of Innovent, stated: "Liver cancer is the third leading cause of cancer death globally, and China accounts for over 50 percent of all new cases and deaths worldwide. The disease is a serious threat to the life and health of Chinese people and a heavy burden on society and families, with hepatocellular carcinoma accounting for 85 to 90 percent of all liver cancer. We are very pleased that TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) – two drugs recognized by the China national innovation drug development project – is the first approved PD-1 inhibitor-based combination therapy for the first-line treatment of people with hepatocellular carcinoma. Innovent is proud to continue delivering on our mission of developing high-quality biopharmaceuticals that are affordable to ordinary people, while also contributing to the 'Healthy China 2030' Plan for cancer prevention and treatment."
About the ORIENT-32 Trial
ORIENT-32 is a Phase 3 randomized, open-label, multi-center study conducted in China to evaluate the efficacy and safety of TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) compared to sorafenib for the first-line treatment of patients with advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT03794440). The primary endpoints of the trial were overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) base...
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