U.S. Markets open in 7 hrs 19 mins

Combination of Tumor Treating Fields with Standard of Care Therapies, Nab-Paclitaxel and Gemcitabine, Suggests Improved Survival of Patients with Advanced Pancreatic Cancer

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

Novocure (NVCR) announced today results from the second cohort of its phase 2 pilot PANOVA trial studying Tumor Treating Fields (TTFields) in combination with nab-paclitaxel and gemcitabine for the treatment of advanced pancreatic cancer. These results will be presented (Abstract CT130) on Tuesday, April 4 at the American Association for Cancer Research Annual Meeting 2017 in Washington, D.C.

The PANOVA trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields (TTFields) in patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The second cohort included 20 patients who received a combination treatment regimen of TTFields plus nab-paclitaxel and gemcitabine.

Median progression free survival in the TTFields-treated group was 12.7 months (compared to 5.5 months in nab-paclitaxel plus gemcitabine historical controls) and median overall survival was not yet reached. The median overall survival was not reached and the one-year survival rate was 72 percent (compared to 35 percent in nab-paclitaxel plus gemcitabine historical controls). Forty percent of the evaluable tumors had partial responses (compared to 23 percent with nab-paclitaxel plus gemcitabine alone) and another 47 percent had stable disease (compared to 27 percent with nab-paclitaxel plus gemcitabine alone). Patients reported no serious adverse events related to TTFields.

“Pancreatic cancer kills more than 300,000 individuals each year worldwide. As the vast majority of pancreatic cancer cases are diagnosed during the late stages, patients with advanced disease are in dire need of additional treatment options,” said Dr. Manuel Benavides, Chief Medical Oncologist at the Hospital Universitario Regional y Virgen de la Victoria in Málaga, Spain. “The phase 2 pilot results look promising, and I look forward to further study of TTFields in pancreatic cancer.”

Novocure is in the final stages of protocol development for a phase 3 pivotal trial studying TTFields in combination with nab-paclitaxel and gemcitabine as a first-line treatment for locally advanced, nonresectable, pancreatic cancer. The company anticipates it will enroll the first patient in the second half of 2017 with data available for presentation approximately 18 months following last patient enrollment.

“We are extremely pleased with these results,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “These data give us hope that TTFields used in combination with other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.”

TTFields are not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The American Cancer Society estimated that about 53,000 people would be diagnosed with pancreatic cancer and about 42,000 people would die from the disease in 2016. Five-year survival among patients with metastatic pancreatic cancer is 2 percent.

About Novocure

Novocure is an oncology company developing a profoundly different cancer treatment centered on 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, Optune, 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 and Japan, and a research center in 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170331005608/en/