ST. HELIER, Jersey--(BUSINESS WIRE)--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.
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.
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.