Novocure Enrolls Last Patient in STELLAR Trial Testing Tumor Treating Fields in Combination with Standard of Care Chemotherapy in Mesothelioma
Interim results from the STELLAR trial, presented in December 2016, suggest improvements in progression free survival and one-year survival rates when TTFields is added to standard chemotherapy
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the last patient has been enrolled in the STELLAR trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) in combination with either pemetrexed and cisplatin or carboplatin in patients with newly diagnosed, unresectable malignant mesothelioma. The final data collection date will be 12 months after the last patient in.
“The interim data presented at International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer were extremely encouraging in a disease where a significant unmet need clearly remains,” said Dr. Uri Weinberg, Novocure’s Vice President of Research and Development. “The one-year survival rates of patients treated with TTFields combined with pemetrexed and cisplatin or carboplatin were more than 50% greater than historical control data.”
The open-label trial includes 80 patients with unresectable, previously untreated malignant mesothelioma. STELLAR’s primary endpoint is overall survival and secondary endpoints are progression free survival, response rate, and treatment-emergent toxicity.
“We look forward to seeing the final results from the STELLAR trial,” said Asaf Danziger, Novocure’s CEO. “The interim data 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.”
Treatment with Tumor Treating Fields (TTFields) is not approved for mesothelioma. The safety and effectiveness of treatment with TTFields for mesothelioma has not been established.
Malignant mesothelioma is a rare thoracic solid tumor cancer that occurs in approximately 3,000 patients in the United States annually. Asbestos exposure has been strongly associated with the development of mesothelioma, which may occur many years following the exposure. The prognosis of mesothelioma patients is very poor, with a median overall survival of approximately 12 months in most reported studies.
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.
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 Investor Contact:
Ashley Cordova, 212-767-7558