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Innovent Releases Phase 3 Results of TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Biosimilar Injection) as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (HCC) at ESMO ASIA Virtual Congress 2020

SAN FRANCISCO and SUZHOU, China, Nov. 22, 2020 /PRNewswire/ — Innovent 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.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, 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. 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 …

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