Vicus Therapeutics Announces Phase II Data Demonstrating Overall Survival Benefit with VT-122 Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma
Eleven-month Increase in Median OS Reported with VT-122 plus Sorafenib, Compared to Sorafenib Alone
Data Presented at International Liver Cancer Association Conference
MORRISTOWN, N.J., Sept. 5, 2014 – Vicus Therapeutics, an immuno-oncology company focused on bringing breakthrough immunotherapies to patients with solid-tumor cancers, announced positive results from a Phase II randomized, open-label, controlled clinical trial of its lead compound, VT-122, in combination with sorafenib, in patients with advanced hepatocellular carcinoma (HCC). In an intent-to-treat (ITT) population, investigators reported an 11-month increase in median overall survival (OS) in patients treated with VT-122 plus sorafenib, compared to those receiving sorafenib alone (21 months vs. 10 months, respectively; hazard ratio [HR] = 0.14; p < 0.001). These data were presented today at the 8th Annual International Liver Cancer Association (ILCA) conference in Kyoto, Japan.
VT-122 is a novel, oral, chronodosed combination of etodolac, a non-steroidal anti-inflammatory drug (NSAID), and propranolol, a beta-blocker. It is designed to synergistically damp tumor-promoting inflammation and restore a tumor-suppressing immune state by inhibiting two major stress systems that are activated in cancer: prostaglandin and beta-adrenergic signaling.
“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, who heads 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.”
Dr. Bhattacharyya and colleagues presented data from a Phase II, randomized, open-label, controlled study of 24 patients with advanced HCC who were randomized to receive VT-122 plus sorafenib or sorafenib alone.
Of the 12 patients receiving VT-122 plus sorafenib, 10 (83.3%) were alive at 12 months, compared to 3 of 12 patients (25%) in the sorafenib-only group (HR = 0.14; p = 0.004). VT-122 was well-tolerated in the study, with no unexpected serious adverse events reported.
The addition of VT-122 to sorafenib was also associated with stabilization of weight loss and reduced incidence of hand-foot skin reaction (HFSR), a major dose-limiting side effect of sorafenib therapy. At six months, 42% of patients in the combination therapy arm had gained more than 5% of total body weight and none had lost more than 5% of body weight. In contrast, 50% of patients receiving sorafenib alone had lost more than 5% of their body weight at six months, and none had gained more than 5% of their body weight (p < 0.05). In addition, only 17% of patients treated with VT-122 plus sorafenib experienced grade 2 HFSR, compared to 67% receiving sorafenib alone (p < 0.05).
“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,” said Newell F. Bascomb, Ph.D., Executive Vice President Research and COO at Vicus Therapeutics. “The latest results strengthen the rationale for combination immunotherapy as a promising approach in oncology.”
“Hepatocellular carcinoma is a devastating disease,” added John Maki, President and CEO at Vicus Therapeutics. “This study has provided us with a unique opportunity to advance VT-122 into further development in a population with few attractive treatment options.”
About Vicus Therapeutics
Vicus Therapeutics (www.vicusrx.com) is an immuno-oncology company bringing breakthrough immunotherapies to patients with solid-tumor cancers. Vicus’ lead drug product, VT-122, is a novel combination of etodolac and propranolol and is the first immunotherapy to inhibit both prostaglandin and beta-adrenergic signaling to the immune system. With its dual mode of action, unique chrono-pharmacodynamic properties, convenient oral dosing, and the well-established safety profiles of its component drugs, VT-122 has the potential to enhance the clinical benefit of proven anticancer therapies. VT-122 is currently being investigated in combination with sorafenib in a Phase II clinical study of patients with advanced liver cancer (http://clinicaltrials.gov/show/NCT01265576); in combination with androgen inhibition therapy in a Phase II clinical study involving patients with prostate cancer prior to chemotherapy (http://clinicaltrials.gov/show/NCT01857817); and in combination with standard-of-care anticancer therapies in investigator-initiated studies of brain, pancreatic, and other solid-tumor cancers.