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 data from the ORIENT-32 study have been published in The Lancet Oncology.
Led by Professor Fan Jia from Zhongshan Hospital of Fudan University, ORIENT-32 is a Phase 2/3 randomized, open label, multi-center study conducted in China to evaluate the efficacy and safety of sintilimab in combination with the bevacizumab biosimilar IBI305 compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (HCC).
In January 2021, the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for sintilimab in combination with bevacizumab biosimilar as first-line therapy for patients with HCC.
Professor Fan Jia stated: "ORIENT-32 is the first large-scale study to show the benefit of first-line treatment in HBV-associated HCC with combination immunotherapy. Despite the COVID-19 pandemic, the collaborative joint effort of the ORIENT-32 trial investigators and patients enabled us to successfully reach this milestone. We hope these results can help to provide a new treatment option for patients with hepatocellular carcinoma."
Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "ORIENT-32 is the first hepatocellular carcinoma study in the world of a PD-1 inhibitor-based combination therapy to achieve its primary endpoint of overall survival. We are pleased that these study results have been published in The Lancet Oncology and hope to bring this regimen as a new treatment option for Chinese patients with hepatocellular carcinoma in the near future. Moreover, we are encouraged that our development of cancer therapies is helping to achieve the Healthy China 2030 goal."
About the ORIENT-32 Study
Background
China has a high burden of hepatocellular carcinoma (HCC), with chronic hepatitis B virus (HBV) infection as the major cause. People with HCC have a poor prognosis and a substantial unmet clinical need1. The ORIENT-32 study assessed sintilimab in combination with bevacizumab biosimilar, compared to sorafenib, in the first-line treatment of patients with unresectable HBV-associated HCC.
China has a high burden of hepatocellular carcinoma (HCC), with chronic hepatitis B virus (HBV) infection as the major cause. People with HCC have a poor prognosis and a substantial unmet clinical need1. The ORIENT-32 study assessed sintilimab in combination with bevacizumab biosimilar, compared to sorafenib, in the first-line treatment of patients with unresectable HBV-associated HCC.
Methods
This randomized, open label study was conducted at 50 clinical trial sites in China. Patients aged 18 years or older with histologically or cytologically diagnosed or clinically confirmed unresectable or metastatic HCC with no previous systemic treatment and a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 were eligible for inclusion.
In the safety lead-in phase, patients received intravenous sintilimab (200 mg every 3 weeks) plus intravenous bevacizumab biosimilar (15 mg/kg every 3 weeks). In the Phase 3 study, patients were randomly assigned (2:1) to receive either sintilimab plus bevacizumab biosimilar (the sintilimab–bevacizumab biosimilar group) or sorafenib (400 mg orally twice daily; the sorafenib group), until disease progression or unacceptable toxicity. Randomization was done using permuted block randomization, with a block size of...
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