VT-122, sorafenib improved OS in patients with HCC

Patients with advanced hepatocellular carcinoma had an increased overall survival rate after treatment with a novel combination of etodolac and propranolol plus sorafenib compared with patients treated with only sorafenib, according to a news release.

In an open-label, phase 2 clinical trial, 12 patients with advanced HCC were randomly assigned oral, chrono-dosed etodolac and propranolol (VT-122, Vicus Therapeutics) and sorafenib. They had a median overall survival rate of 21 months vs. 10 months for 12 patients assigned only sorafenib. Data were presented recently at the International Liver Cancer Association conference in Japan.

Gouri Shankar Bhattacharyya

“Results of this proof-of-concept trial provide the first evidence that VT-122 is active in hepatocellular carcinoma and suggest a demonstrable survival benefit in patients with advanced disease who are receiving the standard-of-care therapy, sorafenib,” researcher Gouri Shankar Bhattacharyya, MD, director of the department of medical oncology at Fortis Hospital, India, said in the release. “Coupled with the growing body of evidence suggesting that the use of NSAIDs and beta-blockers are associated with significant improvement in overall survival in patients with cancer, these results provide a strong basis for advancing VT-122 into further studies for this difficult-to-treat population.”

Eighty-three percent of patients assigned VT-122 with sorafenib were alive at 12 months vs. 25% of patients treated with sorafenib only (P=.004), the release said. VT-122 was well-tolerated and no serious adverse events were reported.

“VT-122 … appears to be a safe, potent and synergistic inhibitor of signaling pathways in the tumor microenvironment and the neuroimmune system,” Newell F. Bascomb, PhD, executive vice president of research and chief operating office at Vicus, said in the release. “The latest results strengthen the rationale for combination immunotherapy as a promising approach in oncology.”