Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announced that the results of the Phase 3 ORIENT-32 study were released in a late-breaking proffered oral presentation at the European Society of Medical Oncology Asia ("ESMO Asia") Virtual Congress 2020.
ORIENT-32 is the first randomized Phase 3 study reporting the efficacy and safety of an anti-PD-1 antibody-based combination therapy versus sorafenib as the first-line treatment in patients with advanced unresectable hepatocellular carcinoma (HCC). A total of 571 patients were enrolled in the trial. 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 Independent Radiographic Review Committee (IRRC) progression-free survival (PFS) versus sorafenib. Compared to sorafenib, TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) demonstrated a 43.1% decreased risk of all-cause mortality (HR 0.569, 95%CI: 0.431-0.751, P<0.0001); the median OS was not reached in the TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) arm versus 10.4 months in the sorafenib arm. TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) also demonstrated 43.5% decreased risk of progression as assessed by IRRC (HR 0.565 95%CI: 0.455-0.701, P<0.0001); median PFS was 4.6 months in the TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) arm versus 2.8 months in the sorafenib arm.
The significantly improved OS and PFS benefits brought by TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) over sorafenib were generally consistent across all subgroups. The combination regimen showed an acceptable safety profile with no new safety signals. With these results, TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) could potentially provide a new option for the first-line treatment of patients with advanced HCC
