(NVCR) Phase 3 Pivotal Glioblastoma Trial Results Selected For Major Cancer Report
Novocure’s (NASDAQ: NVCR) phase 3 pivotal clinical trial results of Tumor Treating Fields (TTFields) in combination with temozolomide in newly diagnosed glioblastoma (GBM) have been selected for inclusion in the American Society of Clinical Oncology’s Clinical Cancer Advances 2016: Annual Report on Progress Against Cancer. The report, which was published first online on Feb. 4 in the Journal of Clinical Oncology, reviews the recent top advances and emerging trends in clinical cancer research that are leading to improved cancer treatments for patients.
“Clinical Cancer Advances 2016 represents and acknowledges the collective wisdom that has made progress against cancer possible,” ASCO President Julie M. Vose wrote in the report. “I hope these achievements will inspire all of us to do our part to further accelerate the pace of research and discovery to help millions of people who are living with cancer and the millions more who will face a cancer diagnosis in their lifetime.”
Novocure’s phase 3 pivotal trial compared TTFields therapy in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial met its endpoints at the interim analysis. The trial’s results demonstrated superior progression-free and overall survivals in patients receiving TTFields therapy in combination with temozolomide compared to temozolomide alone (median progression-free survival of 7.2 months compared to 4.0 months, hazard ratio=0.62, p=0.001; median overall survival of 20.5 months compared to 15.6 months, hazard ratio=0.66, p=0.004).
In October 2015, the U.S. Food and Drug Administration approved Optune – a portable, non-invasive device that delivers TTFields – in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma. TTFields are the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of overall survival in newly diagnosed GBM, with a two-year survival of 48 percent versus 32 percent compared to temozolomide alone.
“We are honored that our research has been selected as a top advancement in cancer care by ASCO, a leading organization in oncology research and education,” said Novocure CEO Asaf Danziger. “Such advancements are critical to improving treatment and extending the lives of cancer patients. We are proud to receive this designation and believe it will help raise awareness of the benefits of TTFields therapy within the broader oncology community.”
About Novocure
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, 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.
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 Quarterly Report on Form 10-Q filed on Oct. 27, 2015, 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.
Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com
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