Innovent Biologics Inc (HKEX: 01801), a biopharmaceutical company, has revealed results of a phase three ORIENT-32 study in a late-breaking proffered oral presentation at the European Society of Medical Oncology Asia (ESMO ASIA) Virtual Congress 2020, it was reported on Sunday.

The study is the first randomised phase three study revealing the efficacy and safety of an anti-PD-1 antibody-based combination therapy compared to sorafenib as the first-line treatment in patients with advanced unresectable hepatocellular carcinoma (HCC). The company has enrolled a total of 571 patients in the trial. The main endpoints of the trial are overall survival and progression-free survival as evaluated by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. Based on an interim analysis conducted by the study's Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) demonstrated significantly improved overall survival (OS) and IRRC progression-free survival (PFS) versus sorafenib.

Dr Hui Zhou, vice president and head of Oncology Strategy and Medical Sciences for Innovent, said, '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. Despite the challenges and impact from the COVID-19 pandemic, the ORIENT-32 study was carried out smoothly and successfully under the joint efforts of all investigators and patients with their families. We are very pleased to see that the ORIENT-32 study demonstrated significant prolongation of OS and PFS in advanced HCC patients in China. With these encouraging results we will apply to the National Medical Products Administration for the new drug application of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection). We look forward to this potentially becoming a new treatment regimen that could help more patients with HCC to live longer without their disease worsening.'