Novocure Enrolls the First Patient in its Phase II STELLAR Trial of Tumor Treating Fields Together with Pemetrexed and Cisplatin or Carboplatin for the Treatment of Malignant Mesothelioma
STELLAR will test the efficacy and safety of Tumor Treating Fields applied to the thorax together with standard of care chemotherapy for treatment of mesothelioma
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure, a commercial stage oncology company, announced today that the first patient has been enrolled in the STELLAR trial, an open-label, single-arm Phase II trial of Tumor Treating Fields (TTFields) together with pemetrexed and cisplatin or carboplatin in patients with newly diagnosed, unresectable malignant mesothelioma. STELLAR is anticipated to enroll 80 patients from Germany, Italy and Poland.
“STELLAR was designed following positive results treating preclinical models of mesothelioma with TTFields,” said Uri Weinberg, MD, PhD, Vice President, Research and Development at Novocure. “A pilot study in non-small-cell lung cancer has already demonstrated high tolerability and safety of TTFields applied to the thoracic region and we are pleased to expand clinical testing to other cancers in this anatomical region.”
“We have long waited to test a novel therapy in mesothelioma and are proud to pioneer enrollment in the STELLAR trial,” said Giovanni Luca Ceresoli, MD, Head of the Thoracic and Genito-Urinary Oncology Unit at the Humanitas Hospital in Bergamo, Italy, who enrolled the first patient under the STELLAR protocol. “Due to the clinical and pathological course of this cancer, standard treatment methods rarely lead to a complete cure and new effective treatments are not available. TTFields have been shown to be safe in non-small-cell lung cancer patients and we believe TTFields could be an ideal treatment for the locally-spreading mesothelioma tumor.”
“Novocure is committed to testing TTFields in multiple solid tumor cancers,” said Asaf Danziger, Chief Executive Officer of Novocure. “While large, Phase III trials are planned in highly prevalent lung and brain cancers later in 2015, we will continue to investigate TTFields in rare cancers with limited effective treatment options.”
STELLAR is an open-label Phase II clinical trial designed to test the efficacy and safety of TTFields together with pemetrexed combined with cisplatin or carboplatin in patients with unresectable, previously untreated malignant mesothelioma, compared to a historical, published control. STELLAR is anticipated to enroll 80 patients from Germany, Italy and Poland. For more information, please refer to www.clinicaltrials.gov.
About Malignant Mesothelioma
Malignant mesothelioma is a rare thoracic malignancy 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 median overall survival is approximately 12 months in most reported studies.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death. TTFields therapy is not approved for the treatment of mesothelioma. The safety and effectiveness of TTFields therapy in mesothelioma has not been established.
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Ashley Cordova, 212-767-7558