MORRISTOWN, N.J.—Immuno-oncology company Vicus Therapeutics has shared positive results from its Phase 2 randomized, open-label controlled clinical trial of VT-122, its lead compound, in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC). In an intent-to-treat population, the study saw an 11-month increase in median overall survival (OS) in patients treated with VT-122 and sorafenib—21 months—compared to sorafenib alone—10 months. the company presented the data at the 8th Annual International Liver Cancer Association conference.
“VT-122, a product of our Precision Medicine modeling technology, appears to be a safe, potent, and synergistic inhibitor of signaling pathways in the tumor microenvironment and the neuroimmune system,” Newell F. Bascomb, Ph.D., executive vice president of Research and chief operating officer at Vicus Therapeutics, said in a press release. “The latest results strengthen the rationale for combination immunotherapy as a promising approach in oncology.”
VT-122 is a novel, oral chronodosed combination of etodolac, a non-steroidal anti-inflammatory drug, and the beta-blocked propranolol. The compound synergistically dampens inflammation that promotes tumor growth and restores a tumor-suppressing immune state by inhibiting prostaglandin and beta-adrenergic signaling, two major stress systems that are activated in cancer.
The study split 24 patients into two equal groups, those receiving the combined therapy and those receiving sorafenib as a monotherapy. Of the former group, 83.3 percent (10 patients) were alive at 12 months, compared to 25 percent (3 patients) in the single therapy group. The drug proved to be well tolerated in the study, with no unexpected serious adverse events.
Combining VT-122 and sorafenib also resulted in a stabilization of weight lose and reduced incidence of hand-foot skin reaction (HFSR), which is a significant dose-limiting side effect of treatment with sorafenib. At six months, 42 percent of those in the combination arm had gained more than 5 percent of their total body weight, with none losing more than 5 percent of body weight. In the sorafenib-only arm, however, 50 percent of patients had lost more than 5 percent of their body weight at six months, and none had gained more than 5 percent. Only 17 percent of patients in the combination arm suffered grade 2 HFSR, compared to 67 percent in the sorafenib-only arm.
“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,” said Principal Investigator Dr. G.S. Bhattacharyya, heads of the Department of Medical Oncology at Fortis Hospitals in Kolkata, India. “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.”
“Hepatocellular carcinoma is a devastating disease,” John Maki, president and CEO at Vicus Therapeutics, commented in a statement. “This study has provided us with a unique opportunity to advance VT-122 into further development in a population with few attractive treatment options.”
SOURCE: Vicus Therapeutics press release