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Final data collection will occur in six months
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<0.001) versus each treatment alone.1 Tumor Treating Fields delivered at 150 kHz plus sorafenib led to reduced viability and clonogenicity, as well as increased apoptosis and autophagy in vitro and to a significant reduction in tumor volume in vivo.2
Treatment with Tumor Treating Fields is not approved for liver cancer. The safety and effectiveness of treatment with Tumor Treating Fields for liver cancer has not been established.
About Liver Cancer
Liver cancer is a leading cause of cancer deaths worldwide and is the fifth leading cause of cancer deaths annually in the U.S. The incidence of liver cancer is approximately 38,000 new cases annually in the U.S., approximately 82,500 new cases annually in Europe, and approximately 35,500 new cases annually in Japan. The five-year survival rate with existing standards of care is less than 18 percent.
Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver. Advanced liver cancer has spread either to the lymph nodes or to other organs, and because these cancers are widespread, they cannot be treated with surgery. The current common standard treatment for patients with advanced disease and those who progress on loco-regional therapy is systemic therapy with sorafenib.
About Tumor Treating Fields
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.
Use of Tumor Treating Fields for the treatment of liver cancer is investigational only.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
1 Golib K. et al. AACR 2018, abstract #1865. Wenger C. et al., Ann Oncol. 2017;28(suppl_3).
2 Davidi S, el al. J Clin Oncol. 2020 Feb 01. 38(4_suppl);551. DOI: 10.1200/JCO.2020.38.4_suppl.551.
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