Novocure Receives FDA IDE Approval for its PANOVA 3 Phase 3 Pivotal Clinical Trial in Advanced Pancreatic Cancer
PANOVA 3 will determine the efficacy and safety of Tumor Treating Fields in combination with nab-paclitaxel and gemcitabine
as a frontline treatment for unresectable locally advanced pancreatic cancer
Tumor Treating Fields in combination with nab-paclitaxel and gemcitabine more than doubled progression free survival and the
one-year survival rate compared to historical controls in Novocure’s phase 2 pilot trial in advanced pancreatic cancer
Novocure (NASDAQ: NVCR) announced today that it has received a U.S. Food and Drug Administration Investigational Device
Exemption (IDE) approval to initiate its PANOVA 3 clinical trial. The randomized phase 3 pivotal trial is designed to determine the
efficacy and safety of Tumor Treating Fields (TTFields) with nab-paclitaxel and gemcitabine as a front-line treatment for
unresectable locally advanced pancreatic cancer. PANOVA 3 is Novocure’s third phase 3 pivotal trial initiated to study solid tumors
beyond glioblastoma.
“Despite extensive clinical research, pancreatic cancer is the third leading cause of cancer death in the U.S. in 2017,” said
Daniel D. Von Hoff, M.D., Principal Investigator for the study and Physician in Chief, Distinguished Professor at Translational
Genomics Research Institute in Phoenix. “Nearly all patients with pancreatic cancer are diagnosed when the tumors are no longer
resectable. We must continue evaluating potential new treatments until we improve survival outcomes for patients with pancreatic
cancer.”
PANOVA 3 is a randomized, open-label trial that will include 556 patients with unresectable locally advanced pancreatic cancer.
Patients should have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 and no prior progression or treatment.
Experimental-arm patients will use a TTFields delivery system tuned to 150 kHZ for at least 18 hours a day until the disease
progresses. The primary endpoint is overall survival. The secondary endpoints include progression free survival, local progression
free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, resectability rate and
toxicity.
Novocure accelerated the trial design of PANOVA 3 after learning the results of its phase 2 pilot trial of TTFields plus
nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer. TTFields in combination with nab-paclitaxel and
gemcitabine more than doubled progression free survival and the one-year survival rate compared to nab-paclitaxel and
gemcitabine-treated historical controls.
“PANOVA 3 is Novocure’s third phase 3 pivotal trial beyond glioblastoma, demonstrating our commitment to developing TTFields as
a treatment for a variety of solid tumors,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and
Development. “With the FDA IDE approval in hand, we are now working closely with trial sites and institutional review boards to
open sites and enroll patients as quickly as possible.”
About Pancreatic Cancer
Pancreatic cancer is the third leading cause of cancer death in the U.S. in 2017. Five-year survival among patients with
pancreatic cancer is about 8 percent. The American Cancer Society estimated that about 53,000 people would be diagnosed with
pancreatic cancer and about 43,000 people would die from the disease in 2017. Worldwide, more than 330,000 people die from the
disease every year.
About Novocure
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called
TTFields, the use of 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 TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and
mesothelioma.
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.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements.
Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements
regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical
results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and
other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the
use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words
and terms of similar meaning. Novocure’s performance and financial results could differ 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 23, 2017, 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.
Novocure
Media and Investor Contact:
Ashley Cordova
212-767-7558
acordova@novocure.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20171218005508/en/