Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer

March 22, 2019 Off By BusinessWire

INNOVATE-3 will test the efficacy of Tumor Treating Fields combined
with paclitaxel in patients with recurrent, platinum-resistant ovarian
cancer

ST. HELIER, Jersey–(BUSINESS WIRE)—-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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