Novocure Presents Second Cohort of Phase 2 Pilot PANOVA Trial Results Suggesting Tumor Treating Fields Plus Nab-Paclitaxel and Gemcitabine may be Safe as First-Line Treatment and may Improve One-Year Survival Rate of Patients with Advanced Pancreatic Cancer
Progression free survival and one-year survival rate of patients treated with Tumor Treating Fields plus nab-paclitaxel and gemcitabine were more than double those of nab-paclitaxel and gemcitabine-treated historical controls
No serious adverse events related to TTFields were reported
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) presented data on Dec. 12, 2016, from its phase 2 pilot PANOVA clinical trial at its research and development day suggesting that Tumor Treating Fields (TTFields) plus first-line chemotherapies nab-paclitaxel and gemcitabine may be tolerable and safe in patients with advanced pancreatic cancer. The data also suggested an improved one-year survival rate among patients who received TTFields therapy with nab-paclitaxel and gemcitabine compared to a recent phase 3 trial of patients who received nab-paclitaxel and gemcitabine alone¹. Progression free survival and one-year survival rate of patients treated with TTFields plus nab-paclitaxel and gemcitabine were more than double those of nab-paclitaxel and gemcitabine-treated historical controls¹. Novocure will submit data for presentation at an upcoming medical conference.
The second cohort of the prospective, single-arm study included 20 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 primary endpoint measured the incidence and severity of treatment-related adverse events. Patients reported no serious adverse events related to TTFields. Nine patients suffered from serious adverse events unrelated to TTFields therapy.
“We are extremely pleased with these results,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “The results of the second cohort of our PANOVA trial support our preclinical work that has demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel. We are finalizing plans and are eager to begin a phase 3 pivotal trial in advanced pancreatic cancer.”
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. Tumor Treating Fields (TTFields) therapy is 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.
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in 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 Haifa, 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 March 1, 2016, 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.
1 Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine, The New England Journal of Medicine, October 2013, DOI: 10.1056/NEJMoa1304369
Media and Investor Contact
Ashley Cordova, 212-767-7558