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Innovent Biologics and Eli Lilly have reported the final clinical and biomarker assessment data from the Phase Ib clinical trial of sintilimab in combination with a bevacizumab biosimilar injection to treat advanced hepatocellular carcinoma (HCC).

Co-developed by the companies, sintilimab is an inhibitor of programmed cell death protein 1 (PD-1) and is marketed as TYVYT in China.

An immunoglobulin G4 monoclonal antibody, sintilimab attaches to PD-1 molecules on the surface of T-cells, hindering the PD-1 / PD-Ligand 1 (PD-L1) pathway and revitalises the T-cells to destroy cancer cells. 

Carried out in China, the open-label trial analysed the tolerability, safety and anti-tumour activity of the combination therapy in individuals with local advanced or metastatic HCC, irrespective of the prior systemic therapy or systemic treatment failure.

The trial had dose-escalation and dose-expansion stages.

Findings showed that the safety profile was in line with the data observed in the prior studies of sintilimab plus bevacizumab biosimilar, with no new or unforeseen safety signals reported. 

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Hypertension, proteinuria and fever were the most common therapy-associated adverse events (TRAE) observed in the trial.

In the high-dose and low-dose arms, the occurrence of grade ≥ 3 adverse events was 28.6% and 13.8%, respectively.

The overall response rate (ORR) was reported to be 34%, while the disease control rate (DCR) was 78%.

Furthermore, median progression-free survival (PFS) and median overall survival (OS) were 10.5 months and 20.2 months, respectively.

According to the biomarker analysis data, extended PFS as well as OS were seen in HCC patients with a greater level of CD137 ≥ 31.8pg/mL.

Innovent Biologics senior vice-president Dr Zhou Hui said: “This study showed the clinical data of sintilimab in combination with two different doses of bevacizumab biosimilar, potentially offering more treatment options for physicians. 

“Meanwhile, the exploration of biomarkers for predicting hepatocellular carcinoma immunotherapy will contribute to better treatment options and represent a step towards precise and individualized treatment.”

In October last year, Innovent reported that sintilimab met the prespecified primary endpoint in the ORIENT-31 trial in epidermal growth factor receptor-mutated nonsquamous non-small cell lung cancer patients.