Final data collection will occur in six months
ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that the last patient has been enrolled in the HEPANOVA trial, a phase 2 pilot trial testing Tumor Treating Fields in combination with sorafenib in patients with advanced liver cancer. The final data collection date is six months after the last patient in.
“Tumor Treating Fields therapy has demonstrated efficacy in in vitro and in vivo models of hepatocellular carcinoma,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We believe that Tumor Treating Fields’ mechanism of action is broadly applicable to solid tumor cancers. We look forward to seeing results from the HEPANOVA trial and further exploring the potential of Tumor Treating Fields as a treatment for advanced liver cancer.”
The open-label trial includes 25 patients with advanced hepatocellular carcinoma that are not eligible for surgical resection or local treatments. HEPANOVA’s primary endpoint is overall response rate. Second endpoints include in-field control rate, progression free survival rate at 12 months, overall survival rate at 1 year and distant metastases free survival rate at 1 year. The sample size was based on the ability to detect an overall response rate of 20 percent in patients treated with Tumor Treating Fields compared to the 4.5 percent overall response rate calculated from historical controls.
Tumor Treating Fields have demonstrated efficacy in in vitro and in vivo models of hepatocellular carcinoma and can be delivered to the abdominal region. In preclinical studies, Tumor Treating Fields delivered at 150 kHz reduced both HepG2 and Huh-7D12 cell counts (53 percent to 64 percent) and clonogenic potential (~70 percent). The combined treatment of Tumor Treating Fields and sorafenib led to a significant reduction in the number of HepG2 and Huh-7D12 cells (p