Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer
INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent,
platinum-resistant ovarian cancer
Ovarian cancer is the fifth leading cause of cancer death among women
Novocure (NASDAQ: NVCR) announced today that it has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor
Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. INNOVATE-3 is Novocure’s
fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma.
“Ovarian cancer is one of the most aggressive forms of cancer,” said Professor Ignace Vergote, Chairman of the Department of
Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union. “Most ovarian cancer
patients are diagnosed at an advanced stage, which makes the disease difficult to treat. Current treatment options are not enough
for these patients. We are pleased to begin this trial that has the potential to improve survival in recurrent ovarian cancer.”
INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer.
Patients will be randomized to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating
Fields tuned to 200 kHz until progression. The primary endpoint is overall survival. Secondary endpoints include progression free
survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related
quality of life or death, and quality of life. Patients may have had a maximum of two prior lines of systemic therapy following
diagnosis of platinum-resistance.
Novocure developed the trial design for INNOVATE-3 after learning the results of its phase 2 pilot trial of Tumor Treating
Fields in combination with weekly paclitaxel, the INNOVATE trial. In 31 evaluable patients, the INNOVATE trial suggested a more
than doubling of progression free survival and an improvement in overall survival among patients who received Optune with
paclitaxel compared to paclitaxel alone.
“INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial beyond glioblastoma, demonstrating our commitment to developing Tumor
Treating Fields for a variety of solid tumors,” said Asaf Danziger, Novocure’s Chief Executive Officer. “At Novocure, we strive to
extend survival in some of the most aggressive forms of cancer. Ovarian cancer has been an important area of focus 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 to open sites and enroll patients as quickly as possible.”
About 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 22,500 new cases annually in the United States, approximately 68,000 new
cases annually in Europe, and approximately 10,000 new cases annually in Japan. Tumor Treating Fields is not approved for the
treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of Tumor Treating Fields for
ovarian cancer has not been established.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing
and commercializing its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is a cancer therapy that uses electric
fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product is approved for
the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor 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 in Portsmouth, 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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those set forth in its Annual Report on Form 10-K filed on February 28, 2019, 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.
Media and Investor Contact:
Ashley Cordova
acordova@novocure.com
212-767-7558
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