Clin Cancer Res: A biomarker that predicts response to treatment with sintilimab combined with IBI305 in advanced hepatocellular carcinoma!

Hepatocellular carcinoma (HCC) is one of the most common malignancies and the third leading cause of cancer-related death worldwide
.

The 5-year survival rate for hepatocellular carcinoma patients is only about 5-30 %

5-30 Sorafenib, lenvatinib, regorafenib, cabozantinib, and ramucirumab 10.

In this phase 1b clinical study, a total of 50 patients aged 18-75 years with histologically diagnosed advanced hepatocellular carcinoma received sintilimab (200 mg) in combination with IBI305 (7.
5 or 15 mg/kg) (each 3 weekly courses)
.

We performed baseline serum cytokine profiling of tissue samples using a bead-based multiplex immunoassay and multiplex immunofluorescence to discover novel biomarkers that predict response to VEGF/PD-1 combination therapy in hepatocellular carcinoma

PFS and OS in different groups of patients

Of the 50 patients tested (median age 56 years), 41 (82.
0%) had no prior systemic therapy
.

All patients received at least one dose of study treatment

The overall response rate was 34.

PFS in patients with different CD137 levels

The incidence of grade 3-5 adverse events was higher in the 15 mg/kg group than in the 7.
5 mg/kg group (28.
6% vs 13.
8%)
.

Biomarker analysis showed that patients with clinical benefit had significantly higher serum CD137 levels than those without clinical benefit (median level: 32.

Patients with high CD137 levels had significantly longer progression-free survival than patients with low CD137 levels.

The combination regimen of sintilimab and IBI305 was well tolerated in patients with advanced hepatocellular carcinoma, and the combination regimen of sintilimab and IBI305 with clinical efficacy was well tolerated in patients with advanced hepatocellular carcinoma, and clinically effective

 

Original source:

Original source:

Wen Zhang, et al.

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