Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC

Tarakanovskaya, Marina G; Chinburen, Jigjidsuren; Purevsuren, Genden; Chogsom, Munkhzaya; Batchuluun, Purev; Bat-Ireedui, Purev; Dandii, Dorjiin; Oyungerel, Dandii; Kutsyna, Galyna A; Bain, Allen I.; Jirathitikal, Vichai; Bourinbaiar, Aldar S.

doi:10.1186/2051-1426-3-s2-p200

Cited by 6 publications

(5 citation statements)

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“…Encouraged by complete clearance of lesions in that individual, other HCC patients came forward asking for V5 26. The present report details the outcome of this immunotherapy in 75 non-selected patients with advanced HCC.…”

Section: Resultsmentioning

confidence: 96%

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Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

Tarakanovskaya¹,

Chinburen²,

Batchuluun³

et al. 2017

JHC

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BackgroundAn increasing number of studies is now devoted to immunotherapy of cancer. We evaluated the clinical benefit of hepcortespenlisimut-L (Hepko-V5 [formerly known as V5])—an oral therapeutic vaccine designated by the United States Food and Drug Administration (FDA) as an orphan drug for treatment of hepatocellular carcinoma (HCC). V5 was initially developed by us in 2002 to treat hepatitis B or C viral infections and liver cirrhosis.MethodsThe outcome of open-label Phase II trial of daily dose of V5 pill was analyzed retrospectively. Over a period of 5 years, 75 patients with advanced HCC were enrolled, consisting of 29 (38.7%) females and 46 (61.3%) males with a median age of 60 years (mean 61.6±8.1 years). Out of these, 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. Most patients (94.7%) had underlying liver cirrhosis of varying severity.ResultsAfter a median of 2 months of treatment, 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). 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). The decrease in AFP was correlated either with tumor clearance or regression on computed tomography scans. The median overall survival time could not be established since 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 first patient in this study received immunotherapy 5 years ago and still remains in complete remission. None of the patients experienced any serious adverse effects or toxicity.ConclusionThe results indicate that hepcortespenlismut-L is a safe, effective, and fast-acting immunomodulatory intervention for HCC. The Phase III, randomized, double-blind, placebo-controlled trial is now initiated at the Mongolian National Cancer Center to confirm these promising findings.

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Section: Resultsmentioning

confidence: 96%

“…Here, we present detailed account of earlier reported conference abstract on hepcortespenlisimut-L (Hepko-V5) intervention in a 75-patient cohort in advanced stage of HCC. 26 …”

Section: Introductionmentioning

confidence: 99%

Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

Tarakanovskaya¹,

Chinburen²,

Batchuluun³

et al. 2017

JHC

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“…Immune checkpoint blockade with antibodies targeting B7 immunoglobulin superfamily molecules such as CTLA-4, PD-1, and PD-L1 is showing promising clinical activity in multiple GI tumors including esophageal, gastric, colorectal, and liver cancers. In fact, one of the most significant achievements witnessed in the field of immunotherapy has been the success of PD-1 pathway blockade in MSI-Hi colorectal and noncolorectal tumors [76][77][78][79][80]. The therapeutic strategy of combining immune checkpoint inhibitors with additional immunostimulatory therapies, targeted agents, chemotherapy drugs, or radiotherapy appears to be a promising approach that might help further unleash the antitumor immunity against several types of GI cancers.…”

Section: Esophageal Cancermentioning

confidence: 99%

A Review of Modern Immunotherapy in Gastrointestinal Malignant Tumors

Yusupbekov

Kamishov

Adilkhodjaev

et al. 2020

EUS

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Gastrointestinal (GI) cancers are a group of highly aggressive malignancies with a huge disease burden worldwide. There is clearly a significant unmet need for new drugs and therapies to further improve the treatment outcomes of GI malignancies. Immunotherapy is a novel treatment strategy that is emerging as an effective and promising treatment option against several types of cancers. CTLA-4 and PD-1 are critical immune checkpoint molecules that negatively regulate T cell activation via distinct mechanisms. Immune checkpoint blockade with antibodies directed against these pathways has already shown clinical efficacy that has led to their FDA approval in the treatment of several solid tumors including melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, and head and neck cancer. This review will summarize the current clinical progress of modern immunotherapy in the field of GI tumors, with a special focus on immune checkpoint blockade

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“…A randomized phase III study to compare the efficacy and tolerability of Pexa-Vec followed by sorafenib versus sorafenib alone in patients with advanced HCC is currently ongoing (PHOCUS, NCT02562755). Another oral therapeutic vaccine, hepcortespenlisimut-L, is currently being evaluated in an ongoing phase III clinical trial (NCT02232490) after it demonstrated encouraging activity in the phase II study [ 75 ].…”

Section: Hepatocellular Carcinomamentioning

confidence: 99%

Role of modern immunotherapy in gastrointestinal malignancies: a review of current clinical progress

Myint

Goel

2017

J Hematol Oncol

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Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC

Cited by 6 publications

References 0 publications

Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

A Review of Modern Immunotherapy in Gastrointestinal Malignant Tumors

Role of modern immunotherapy in gastrointestinal malignancies: a review of current clinical progress

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