INNOVATE-3 will test the efficacy of Tumor TreatingFields combined with paclitaxel in patients with recurrent, platinum-resistantovarian cancer
Ovarian cancer is the fifth leading cause of cancerdeath among women
ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ:NVCR) announced today that it has initiated INNOVATE-3, a phase 3 pivotal trialtesting the efficacy of Tumor Treating Fields combined with paclitaxel inpatients with recurrent, platinum-resistant ovarian cancer. INNOVATE-3 isNovocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyondglioblastoma.
“Ovarian cancer is one of the most aggressive forms ofcancer,” said Professor Ignace Vergote, Chairman of the Department ofObstetrics and Gynaecology and Gynaecologic Oncology at the Catholic Universityof Leuven, European Union. “Most ovarian cancer patients are diagnosed at anadvanced stage, which makes the disease difficult to treat. Current treatmentoptions are not enough for these patients. We are pleased to begin this trialthat has the potential to improve survival in recurrent ovarian cancer.”
INNOVATE-3, a prospective, open-label study, will include540 patients with recurrent, platinum-resistant ovarian cancer. Patients willbe randomized to receive either weekly paclitaxel alone or weekly paclitaxel incombination with Tumor Treating Fields tuned to 200 kHz until progression. Theprimary endpoint is overall survival. Secondary endpoints include progressionfree survival, objective response rate, severity and frequency of adverseevents, time to undisputable deterioration in health-related quality of life ordeath, and quality of life. Patients may have had a maximum of two prior linesof systemic therapy following diagnosis of platinum-resistance.
Novocure developed the trial design for INNOVATE-3 afterlearning the results of its phase 2 pilot trial of Tumor Treating Fields incombination with weekly paclitaxel, the INNOVATE trial. In 31 evaluablepatients, the INNOVATE trial suggested a more than doubling of progression freesurvival and an improvement in overall survival among patients who receivedOptune with paclitaxel compared to paclitaxel alone.
“INNOVATE-3 is Novocure’s fourth phase 3 pivotal trialbeyond glioblastoma, demonstrating our commitment to developing Tumor TreatingFields for a variety of solid tumors,” said Asaf Danziger, Novocure’s ChiefExecutive Officer. “At Novocure, we strive to extend survival in some of themost aggressive forms of cancer. Ovarian cancer has been an important area offocus for our research because of the great unmet need faced by these patients.We are now working closely with trial sites and institutional review boards toopen sites and enroll patients as quickly as possible.”
About Ovarian Cancer
In the United States, ovarian cancer ranks fifth in cancerdeaths among women, accounting for more deaths than any other cancer of thefemale reproductive system. Ovarian cancer incidence increases with age, andthe median age at time of diagnosis is 63 years old. The incidence of ovariancancer is approximately 22,500 new cases annually in the United States,approximately 68,000 new cases annually in Europe, and approximately 10,000 newcases annually in Japan. Tumor Treating Fields is not approved for thetreatment of ovarian cancer by the U.S. Food and Drug Administration. Thesafety and effectiveness of Tumor Treating Fields for ovarian cancer has notbeen established.
Novocure is a global oncology company working to extendsurvival in some of the most aggressive forms of cancer by developing andcommercializing its innovative therapy, Tumor Treating Fields. Tumor TreatingFields is a cancer therapy that uses electric fields tuned to specificfrequencies to disrupt solid tumor cancer cell division. Novocure’scommercialized product is approved for the treatment of adult patients withglioblastoma. Novocure has ongoing or completed clinical trials investigatingTumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer,pancreatic cancer, ovarian cancer and liver cancer.
Headquartered in Jersey, Novocure has U.S. operations inPortsmouth, 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.
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