Feasibility study of personalized peptide vaccination for hepatocellular carcinoma patients refractory to loco-regional therapies

Summary

Overall survival (OS) of patients with hepatocellular carcinoma (HCC) refractory to loco-regional therapy is dismal even by treatment with sorafenib, a multi-kinase inhibitor. To develop a more efficacious treatment modality, we conducted a feasibility study of personalized peptide vaccination (PPV) for HCC, in which the peptides were selected from 31 peptide candidates based on the pre-existing immunity. Twenty-six HCC patients refractory to loco-regional therapies (Cohort 1) and 30 patients refractory to both loco-regional and systemic therapies (Cohort 2) were entered to the study. There were no severe adverse events related to PPV except for one injection site reaction. At the end of the 1^st cycle of 6 vaccinations, successful CTL or IgG boosting was observed in 57% or 46% in the Cohort 1 and in 54% or 52% in the Cohort 2, respectively. Successful IgG boosting at the end of 2^nd cycle was observed in the majority of patients tested. Median OS of the Cohort 1 or Cohort 2 was 18.7 months (M) (95%CI: 12.2-22.5 M) or 8.5 M (95% CI: 5.9-12.2 M), respectively. Based on the higher rates of immune boosting and safety profile of PPV, further clinical studies of PPV would be warranted for patients with HCC refractory to not only loco-regional therapy but also both loco-regional and systemic therapies.

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