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Benefits Reported With VT-122 for Advanced Liver and Pancreatic Cancers
Two studies demonstrated a safety and survival benefit for VT-122 (Vicus Therapeutics) when combined with standard-of-care therapy in patients with advanced liver and pancreatic cancers, according to presentations at the 2015 Gastrointestinal Cancers Symposium in San Francisco.
VT-122 is a novel, chrono-modulated combination of the nonelective beta-adrenergic receptor blocker propranolol and the COX-2-selective nonsteroidal anti-inflammatory drug etodolac.
A phase 2 trial evaluated the safety, tolerability, and efficacy of VT-122 in patients with advanced hepatocellular carcinoma receiving sorafenib as standard-of-care, first-line therapy. The double-blind, multicenter study assessed 20 patients 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 of 11 [45.5%] vs. 3 of 9 [27.3%]). Additionally, median overall survival (OS) 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.
In the second study, a single-center, open-label, investigator-led trial, 37 patients with advanced pancreatic cancer were randomly assigned to receive either VT-122 (n = 20) or placebo (n = 17) in addition to gemcitabine and a nanoparticle albumin-bound paclitaxel (GemNab). The VT-122 regimen was initiated one week prior to starting GemNab and then administered in combination with GemNab chemotherapy. Although follow-on lines of chemotherapy after disease progression were not administered, VT-122 treatment was continued after discontinuation of GemNab upon disease progression.
The use of VT-122 was associated with an increase in median OS of 7.7 months (9.3 to 17 months; hazard ratio, 0.10; 95% confidence interval, 0.035– 0.282; P < 0.001), compared to that observed with GemNab alone. Additionally, no treatment-associated serious adverse events were reported in the study.
The company expects to initiate approval-enabling phase 2 and 3 studies this year.
Source: Vicus Therapeutics; January 16, 2015.