ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today results from its phase 2 pilot INNOVATE trial studying Tumor Treating Fields (TTFields) in combination with weekly paclitaxel for the treatment of recurrent ovarian cancer. These results will be presented (Abstract CT135) on Tuesday, April 4 at the American Association for Cancer Research Annual Meeting 2017 in Washington, D.C.
The INNOVATE trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields (TTFields) combined with weekly paclitaxel in recurrent ovarian cancer. Thirty-one patients with recurrent platinum-resistant ovarian cancer patients were enrolled.
Median progression free survival in the TTFields-treated group was 8.9 months (compared to 3.9 months in paclitaxel alone historical controls) and median overall survival was not yet reached. Median one-year survival was 61 percent. The median compliance of patients with TTFields in the first 3 months was 77 percent. Two cases of severe skin irritation due to TTFields were reported. No other serious device-related adverse events were reported.
“A clear unmet need remains for patients with recurrent ovarian cancer, particularly in the platinum-resistant population, with median overall survival of only 13 to 14 months post recurrence,” said Dr. Igance Vergote, Chair of the Department of Obstetrics and Gynecology at the Catholic University Leuven in Leuven, Belgium. “These data show that treatment with TTFields has the potential to make a difference in the lives of recurrent ovarian cancer patients.”
“These are encouraging results in a disease state that is very difficult to treat and we are now working to develop a phase 3 pivotal trial protocol to further study TTFields for the treatment of recurrent ovarian cancer,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “These data give us hope that TTFields used in combination with other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.”
TTFields are not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2016, there were approximately 22,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old.
About Novocure
Novocure is an oncology company developing a profoundly different cancer treatment centered on a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
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 and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Forward-Looking Statements
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, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, 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 more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, 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.
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