The results of its INNOVATE phase 2 pilot trial have been published in Gynecologic Oncology.
The INNOVATE trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumour Treating Fields combined with weekly paclitaxel in recurrent ovarian cancer.
In the United States, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.
Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old.
The incidence of ovarian cancer is approximately 22,000 new cases annually in the United States, approximately 68,000 new cases annually in Europe, and approximately 10,000 new cases annually in Japan.
Tumour Treating Fields is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration.
Their safety and effectiveness for ovarian cancer has not been established.
Tumour Treating Fields (TTF) is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumour growth and causing affected cancer cells to die.
Progression free survival of recurrent ovarian cancer patients treated with TTF plus weekly paclitaxel was more than double that of weekly paclitaxel-treated historical controls.
“A clear unmet need remains for patients with recurrent ovarian cancer, particularly for those patients resistant to platinum-based chemotherapy, with median overall survival of about 13 months post recurrence,” said Dr. Ignace Vergote, Chairman of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union, and an investigator in the trial. “These phase 2 pilot data show that TTF combined with paclitaxel has the potential to increase survival without significantly increasing side effects for recurrent ovarian cancer patients.”
Median progression free survival in the TTF-treated group (n=31) 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 in the TTF-treated group was 61 percent.
The median compliance of patients with TTF in the first three months of treatment was 77 percent.
Two cases of severe skin irritation due to TTF were reported.
No other serious device-related adverse events were reported.
“These are encouraging results in a disease state that is very difficult to treat,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are now working to open INNOVATE-3, a phase 3 pivotal trial to further study TTF for the treatment of recurrent ovarian cancer.”