Novocure, a commercial stage oncology company,announced 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 ,” says Uri Weinberg, MD, 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,” says 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 tumour.”
“Novocure is committed to testing TTFields in multiple solid tumour cancers, ” says Asaf Danziger,chief executive officer of Novocure. “While large, phase III trial s 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.”