Phase 2 pilot INNOVATE data will be presented at the American
Association for Cancer Research Annual Meeting 2017
Progression free survival of patients treated with Tumor Treating
Fields plus weekly paclitaxel was more than double that of weekly
paclitaxel-treated historical controls
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
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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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Source: Novocure