Novocure (NVCR) Announces Presentation of Positive Interim STELLAR Trial Data in Mesothelioma
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Novocure (Nasdaq: NVCR) announced 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 MesotheliomaPresenter: G.L. CersoliOral Session: Novel Trials and Biomarkers in Malignant Pleural MesotheliomaWednesday, Dec. 7, 2:20 p.m. CET, Strauss 3
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.
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