Mar 31 2017
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.