Patients with advanced, inoperable hepatocellular carcinoma (HCC) may highly benefit from Immunitor‘s new oral immunotherapeutic vaccine, Hepko-V5 (hepcortespenlisimut-L), according to results of a Phase 2 trial.
More than 90 percent of the 75 Mongolian patients with late-stage HCC in the trial were alive after a median follow-up of 12 months — a dramatic improvement over the typical one-year survival rate of 10 percent seen in HCC patients with standard-of-care chemotheraphy, Nexavar (sorafenib).
A study containing these findings, “Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L,” appeared in the Journal of Hepatocellular Carcinoma.
“Close to 90 percent of HCC cases in Mongolia are diagnosed in an advanced stage when common therapeutic interventions, such as resection, chemoembolization, radiofrequency ablation or liver transplantation, are not feasible anymore,” wrote Marina G. Tarakanovskaya and her colleagues, adding that although Nexavar is an available chemo option, “it is seldom used due to high cost and low efficacy combined with adverse effects.”
Therefore, the need for a more effective, cheaper, and safer treatment approach remains unfulfilled.
Hepko-V5 is a tableted, off-shelf formulation of the inactivated blood of hepatitis B and C carriers diagnosed with HCC. Doctors in Mongolia have used it since 2007 to treat chronic viral hepatitis and liver cirrhosis, but its benefits in liver cancer patients have only recently been discovered.
At the time, a patient with viral hepatitis C, liver cirrhosis and inoperable HCC who was given less than three months to live took oral Hepko-V5 pills once a day for four months and saw a complete remission of his cancer.
This led to signup of additional HCC patients, and further positive data led the U.S. Food and Drug Administration to grant orphan drug status to Hepko-V5 for the treatment of HCC patients. Now, researchers reported data from a 75-patient cohort who were treated in an advanced stage of HCC.
Data showed the most recent cohort of 75 patients tolerated the treatment extremely well, with none reporting treatment-related side effects.
“As per previous experience with hepatitis and cirrhosis patients, V5 produced almost immediate relief from symptoms of the disease,” researchers wrote. “Fatigue and abdominal pain or discomfort were the most common symptom reported as improved within one week from treatment initiation.”
After a median treatment duration of two months, 50 patients had a decline in their liver tumor marker, AFP, which was used to assess tumor response. This indicated that two-thirds of patients responded to the tumor vaccine.
Doctors observed complete tumor clearance, deemed as bringing AFP down to normal levels (10 IU/ml), in 12 of the 75 patients, or 16 percent.
Median survival time could not be determined because more than half the patients were alive when the study ended. However, after a median follow-up of 12 months, 90.7 percent of patients were still alive. This contrasts with an average 12-month overall survival rate of 10 percent seen in historical controls treated with Nexavar, in the Phase 3 SHARP study (NCT00105443).
The researchers reported that the first patient received immunotherapy for five years, and still remains in complete remission.
An ongoing Phase 3 trial (NCT02232490), taking place at the Mongolian National Cancer Center in Ulanbataar, is currently assessing Hepko-V5 versus placebo in advanced HCC patients to confirm these positive findings. The trial is currently recruiting participants.