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Two Combination Studies Demonstrate Safety and Survival Benefit for VT-122 in Liver and Pancreatic Cancers

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Key Points

  • VT-122, is a novel, chronomodulated combination of propranolol and etodolac.
  • Coadministration of VT-122 with sorafenib was well tolerated in patients with advanced hepatocellular carcinoma and showed an increase in duration of therapy and overall survival vs sorafenib alone.
  • Administration of VT-122 1 week prior to paclitaxel protein-bound particles with gemcitabine significantly increased progression-free and overall survival in patients with pancreatic cancer.

The immunooncology company Vicus Therapeutics announced the presentation of two separate studies demonstrating a safety and survival benefit for VT-122, the company's lead compound, when combined with standard-of-care therapy in patients with advanced liver and pancreatic cancers. Results from both studies were presented at the 2015 Gastrointestinal Cancers Symposium in San Francisco (Abstract 390 and Abstract 302).

Novel Combination

VT-122 is a novel, chronomodulated combination of the nonselective beta-adrenergic receptor blocker propranolol and the COX-2–selective nonsteroidal anti-inflammatory drug etodolac. In one study, a phase II trial in patients with advanced hepatocellular carcinoma, administration of VT-122 30 days after initiation of sorafenib (Nexavar) therapy was generally well tolerated and associated with an increase in 12-month survival and median overall survival, compared to sorafenib alone.

In the other study, the combination of VT-122 plus gemcitabine and a nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) was associated with increased median overall survival in patients with locally advanced and metastatic pancreatic cancer, compared to patients treated with gemcitabine/nab-paclitaxel alone. No treatment-associated serious adverse events were reported in either study.

“These data add to the growing body of evidence of a safety and survival benefit for VT-122 plus standard therapy in patients with advanced cancers,” commented G.S. Bhattacharyya, MD, study investigator and Head of the Department of Medical Oncology at Fortis Hospitals, India. “We continue to be encouraged by the data emerging from patients receiving VT-122–based combination therapy. In particular, we are most excited about the long-term survival shown in patients with liver and pancreatic cancers. The long-term survival is consistent with VT-122’s unique immune-targeting effects and ability to inhibit tumor-promoting inflammation and tumor evasion of the immune system.”

Hepatocellular Carcinoma Study Highlights

The hepatocellular carcinoma study (Abstract 390) reported by de la Torre et al was designed to evaluate the safety, tolerability, and efficacy of VT-122 in patients receiving sorafenib as standard-of-care, first-line therapy. The double-blind, multicenter study assessed 20 patients with advanced hepatocellular carcinoma who were randomly assigned to receive either VT-122 (n = 11) or placebo (n = 9) on a background of stable-dose sorafenib (initiated 30 days prior to randomization).

Among patients treated with VT-122 plus sorafenib, 12-month survival was greater than that in patients treated with sorafenib alone (5/11 [45.5%] vs 3/9 [27.3%]). Additionally, median overall survival increased by 2.0 to 4.4 months (8.8 to 13.2 months, data still maturing) in the VT-122-treated patients, compared to patients receiving sorafenib alone. Three patients treated with VT-122 have demonstrated durable responses. No treatment-associated serious adverse events were reported in the study.

Pancreatic Cancer Study Highlights

In the second study (Abstract 302), a single-center, open-label, investigator-led trial reported by Bhattacharyya et al, 37 patients with advanced pancreatic cancer were randomly assigned to receive either VT-122 (n = 20) or placebo (n = 17) in addition to gemcitaine/nab-paclitaxel. The VT-122 regimen was initiated 1 week prior to starting gemcitabine/nab-paclitaxel and then administered in combination with gemcitabine/nab-paclitaxel chemotherapy. Although follow-on lines of chemotherapy after disease progression were not administered, VT-122 treatment was continued after discontinuation of gemcitabine/nab-paclitaxel upon disease progression.

The use of VT-122 was associated with an increase in median overall survival of 7.7 months (9.3 to 17 months, hazard ratio = 0.10, 95% confidence interval = 0.035–0.282, P < .001), compared to that observed with gemcitabine/nab-paclitaxel alone. Additionally, no treatment-associated serious adverse events were reported in the study.

“Both studies … support further development of VT-122 for hepatocellular carcinoma and pancreatic cancer,” noted John W. Maki, President and Chief Executive Officer of Vicus Therapeutics. “We look forward to initiating approval-enabling phase II and III studies this year.”

Dr. Bhattacharyya reported a consulting/advisory role with and research funding from Vicus Therapeutics. For full disclosures of the study authors, see the study abstracts at http://gicasym.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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