ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today that data will be presented from STELLAR, its ongoing phase 2 pilot clinical trial in mesothelioma, at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer on Wednesday, Dec. 7, 2016, in Vienna, Austria. The data show that treatment with Tumor Treating Fields (TTFields) plus standard chemotherapy, pemetrexed and cisplatin or carboplatin, was tolerable and safe in patients with unresectable, previously untreated mesothelioma. The interim data also suggest improvements in the 12-month survival rate and progression free survival among patients who received TTFields with standard chemotherapy compared to historical control data of patients who received standard chemotherapy alone.
The STELLAR trial will accrue a total of 80 patients with unresectable, previously untreated mesothelioma. Patients treated with TTFields plus standard chemotherapy, pemetrexed and cisplatin or carboplatin, received TTFields applied to the lungs at the specific frequency of 150 kHz, which has been shown in preclinical studies to be the optimal frequency for inhibiting mitosis of mesothelioma cells. The primary endpoint of the trial is overall survival and secondary endpoints are response rate, progression free survival and treatment-emergent toxicity. The IASLC presentation will include data from the first 42 patients enrolled to the trial with an average follow up time of 11.5 months.
The presentation references as a historical control a phase 3 study of the efficacy and safety of cisplatin plus pemetrexed compared with cisplatin alone in patients with unresectable malignant pleural mesothelioma published in July 2003 in the Journal of Clinical Oncology1 which showed that patients who received cisplatin plus pemetrexed experienced a one year survival rate of 50.3 percent and median progression free survival of 5.7 months.
In relation to these historical control data for cisplatin plus pemetrexed, 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 has not been reached at this time due to limited follow-up time. No device-related serious adverse events have been reported to date.
“The interim STELLAR results are very encouraging,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are pleased that the first clinical results in mesothelioma will be presented at IASLC and look forward to sharing additional data in pancreatic and ovarian cancer at our R&D day in December.”
The full details of the presentation are as follows:
OA22.01 –
STELLAR – Interim Results of a Phase 2 Trial of TTFields with
Chemotherapy for First Line Treatment of Malignant Mesothelioma
Presenter:
G.L. Cersoli
Oral Session: Novel Trials and Biomarkers in Malignant
Pleural Mesothelioma
Wednesday, Dec. 7, 2:20 p.m. CET, Strauss 3
About Mesothelioma
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.
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.
About Novocure
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.
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 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 Vogelzang et al, Journal of Clinical Oncology, Vol 21, No 14 (July 15), 2003: pp 2636-2644
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