Tarakanovskaya MG, et al. – Hepcortespenlisimut–L (Hepko–V5 [formerly known as V5])—an oral therapeutic vaccine was targeted for its clinical benefit for the treatment of hepatocellular carcinoma (HCC). The aforementioned regimen was found to be safe, effective, and fast–acting immunomodulatory intervention for HCC.

Methods

• The clinicians tested the outcome of open-label Phase II trial of daily dose of V5 pill.
• Over a period of 5 years, they recruited 75 patients with advanced HCC, consisting of 29 (38.7%) females and 46 (61.3%) males with a median age of 60 years (mean 61.6±8.1 years).
• 23 (30.7%) had hepatitis B and 34 (45.3%) had hepatitis C infections, including 9 (12%) with dual infection, 4 (5.3%) negative for both viruses, and 5 (6.7%) without established viral diagnosis, among these patients.
• Underlying liver cirrhosis of varying severity was presented in most patients (94.7%).

Results

• 50 out of 75 patients had experienced a decline in serum levels of the tumor marker, alpha-fetoprotein (AFP) (66.7%; P=0.006 by Wilcoxon signed rank test), after a median of 2 months of treatment.
• They reported that baseline median AFP levels were 245.2 IU/mL (mean 4,233; range 7.2–92,407; 95% confidence interval [CI] 1,186–7,280) and post-treatment values were 102.3 IU/mL (mean 2,539; range 0.9–54,478; 95% CI 503–4,575).
• Findings highlighted a correlation of the decrease in AFP either with tumor clearance or regression on computed tomography scans.
• As 68 out of 75 (90.7%) patients were still alive after median follow-up of 12 months (mean 15±9.7; range 7–59; 95% CI 12.8–17.2), the median overall survival time could not be established.
• It was noted that the first patient in this study received immunotherapy 5 years ago and still remains in complete remission.
• No serious adverse effects or toxicity were reported in the patients.