Overall survival and progression-free survival are the primary endpoints of the trial. Credit: Yale Rosen.

Innovent Biologics has reported positive interim analysis results from Phase III ORIENT-32 study of anti-PD-1 antibody-based combination therapy versus sorafenib for treating patients with advanced unresectable hepatocellular carcinoma (HCC).

The combination therapy includes TYVYT (sintilimab injection) and BYVASDA (bevacizumab biosimilar injection).

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TYVYT is an immunoglobulin G4 monoclonal antibody that attaches to PD-1 molecules present on the T-cells. It inhibits the PD-1/ PD-Ligand 1 pathway and reactivates T-cells to destroy cancer cells.

BYVASDA is a recombinant humanised anti-VEGF monoclonal antibody drug.

The randomised, open-label, multi-centre study is analysing the efficacy and safety of TYVYT plus BYVASDA compared to sorafenib in HCC patients.

The study enrolled 571 patients who were randomly given TYVYT plus BYVASDA or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons.

Overall survival (OS) and progression-free survival (PFS) are the primary endpoints of the trial.

Data from the interim analysis by the study’s independent data monitoring committee (IDMC) showed that the combination of both demonstrated significantly improved OS and Independent Radiographic Review Committee (IRRC) PFS versus sorafenib.

The combination therapy showed a 43.1% decreased risk of all-cause mortality as compared to sorafenib. Moreover, it showed a 43.5% decreased risk of progression as assessed by IRRC.

An acceptable safety profile of the therapy was also noted during the trial, with no new safety signals observed.

Innovent Oncology Strategy and Medical Sciences vice-president and head Dr Hui Zhou: “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.”