Participants with HCC received Tyvyt plus Byvasda or sorafenib during the trial. Credit: Yale Rosen.

Innovent Biologics has reported positive results from the Phase III ORIENT-32 clinical trial of a combination of Tyvyt (sintilimab) and Byvasda (bevacizumab or IBI305) in advanced hepatocellular carcinoma (HCC).

Tyvyt is an immunoglobulin G4 monoclonal antibody that binds 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.

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A bevacizumab biosimilar, Byvasda is a recombinant humanised anti-vascular endothelial growth factor (VEGF) monoclonal antibody drug.

ORIENT-32, a randomised, open-label, multi-centre trial, assessed the efficacy and safety of Tyvyt plus Byvasda compared to sorafenib as a first-line treatment for HCC.

Participants in the trial received Tyvyt plus Byvasda or sorafenib until they developed unacceptable toxicity, had disease progression, withdrawal of consent, death, or other reasons.

The combination therapy led to a statistically significant improvement in progression free survival (PFS) and overall survival (OS) when compared to sorafenib, according to data from an interim analysis.

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PFS and OS were the primary endpoints of the study. The safety profile of the combination was consistent with prior study results, without any new safety signals.

This is said to be the first trial of PD-1 inhibitor-based combination therapy to meet the primary endpoints in the first-line treatment of advanced HCC, Innovent said.

HCC is a type of primary liver cancer, which is a common digestive system malignancy, with 50% of new cases and deaths reported in China.

Sorafenib, lenvatinib and chemotherapy are currently primarily used in first-line treatment to treat HCC in China.

Innovent Oncology Strategy and Medical Sciences vice-president and head Dr Hui Zhou said: “The results of the ORIENT-32 study demonstrate the potential of Tyvyt in combination with Byvasda to treat patients with advanced HCC in the first-line setting.”

Over 20 clinical studies of Tyvyt are being carried out to analyse its safety and efficacy in various cancers worldwide, including more than ten registrational or pivotal trials.

In May, Innovent and Eli Lilly reported positive results from the Phase III ORIENT-12 trial of TYVYT in metastatic squamous non-small cell lung cancer (sqNSCLC).