Novocure™ Receives Humanitarian Use Device Designation for Treatment of Pleural Mesothelioma
Novocure (NASDAQ:NVCR) announced today that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating
Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma.
HUD designation covers devices that treat rare, orphan diseases or conditions. The HUD designation is the first step in
obtaining a Humanitarian Device Exemption (HDE) for the treatment of pleural mesothelioma with TTFields. Novocure enrolled the last
patient in its STELLAR trial, a phase 2 pilot trial in pleural mesothelioma, in March 2017 and, with final data collection in 2018,
is evaluating its options to file an HDE application with the STELLAR data. An approved HDE would allow Novocure to market TTFields
in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.
“Due to the clinical and pathological course of mesothelioma, standard treatment methods rarely lead to a complete cure and new
effective treatments are desperately needed. Our interim data from the STELLAR trial give us hope that TTFields used in combination
with standard of care chemotherapies may increase survival for patients with mesothelioma without significantly increasing side
effects,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are pleased that the
FDA has recognized orphan status for mesothelioma and acknowledges the urgent demand for new treatment options.”
Novocure’s ongoing STELLAR trial includes 80 patients with unresectable, previously untreated malignant pleural mesothelioma.
STELLAR’s primary endpoint is overall survival and secondary endpoints are progression free survival, response rate, and
treatment-emergent toxicity. Interim results presented in December 2016 at the International Association for the Study of Lung
Cancer (IASLC) 17th World Conference on Lung Cancer suggest improvements in progression free survival and one-year
survival rates when TTFields is added to standard chemotherapy. Forty-two STELLAR patients who received treatment with TTFields
plus pemetrexed and cisplatin or carboplatin experienced a 12-month survival rate of 79.7 percent and median progression free
survival of 7.3 months. Median survival had not been reached at the time of presentation due to limited follow-up time, with an
average follow-up time of 11.5 months. No device-related serious adverse events were reported.
“We believe that treatment with TTFIelds affects fundamental aspects of cell division and may have broad applicability across a
variety of solid tumors,” said Asaf Danziger, Chief Executive Officer of Novocure. “We are pleased to receive HUD designation as it
is a major step towards a second regulatory approval for TTFields in the United States.”
Treatment with TTFields is not approved for the treatment of mesothelioma by the U.S. Food and Drug Administration. The safety
and effectiveness of TTFields therapy for mesothelioma has not been established.
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, 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.
Media and Investors:
Ashley Cordova, 212-767-7558
acordova@novocure.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20170515005422/en/