Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer
March 22 2019 - 7:30AM
Business Wire
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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statements regarding anticipated scientific progress on its
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materially from those reflected in these forward-looking statements
due to general financial, economic, regulatory and political
conditions as well as more specific risks and uncertainties facing
Novocure such as 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.
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Media and Investor Contact:Ashley
Cordovaacordova@novocure.com212-767-7558
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