-- Phase I/II study showed the addition of NovoTTF Therapy to pemetrexed is safe and potentially more effective than pemetrexed alone for second line NSCLC
ST. HELIER, Jersey, Sept. 4, 2013 /PRNewswire/ -- Results of the first clinical trial to study treatment with tumor treating field therapy (NovoTTF Therapy) in combination with chemotherapy for patients with non-small cell lung cancer (NSCLC) were published in the journal Lung Cancer. The study demonstrated that combining NovoTTF Therapy with pemetrexed (Alimta®, Eli Lilly) chemotherapy was safe and potentially more effective for second line treatment of patients with advanced NSCLC. (Pless M. et al., A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Jul 23. pii: S0169-5002(13)00308-5. doi: 10.1016).
"We were pleased to report on the results of the first multi-center trial of NovoTTF Therapy in a non-brain tumor indication," said Dr. Miklos Pless, Head of the Cancer Center at the Winterthur Hospital in Switzerland and lead author of the study. "We believe this study has shown the therapy to be safe, well tolerated and to have the potential to act as a significant adjunct to chemotherapy in the treatment of NSCLC."
The trial, known as the EF-15 Study, was conducted at four leading cancer centers in Switzerland and enrolled 42 patients who had already received first line chemotherapy for their disease. Patients had histologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for surgery or radiation (stage IIIB or IV). All patients received standard pemetrexed therapy once every three weeks together with continuous NovoTTF Therapy. The combination of NovoTTF Therapy and pemetrexed was well tolerated, and skin irritation beneath the transducer arrays was the only device related adverse event.
The EF-15 Study results demonstrated a median progression free survival for the combined therapy of more than five months, and an overall survival of 13.8 months. These results compare favorably to historical results for second line treatment of advanced NSCLC with pemetrexed alone. Notably, the EF-15 Study also included patients with squamous histology (n=7, 17%), who do not respond to pemetrexed treatment.
"Publication of the EF-15 Study results is another major clinical milestone for Novocure, presenting additional evidence of the additive effect of NovoTTF Therapy in combination with chemotherapy, as well as the first phase II data of NovoTTF Therapy in a non-CNS tumor indication," said Angela M. Davies, M.D., Novocure's Chief Medical Officer. "We look forward to working with the principal investigators to advance our lung cancer program to a randomized clinical trial."
About the NovoTTF™-100L System
The NovoTTF-100L System is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The system delivers NovoTTF Therapy to the chest and abdomen. The system has been shown in both in vitro and in vivo studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100L System creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. The NovoTTF-100L System is a CE Marked device cleared for sale in the European Union, and Switzerland. The device is not approved for the treatment of NSCLC in the United States. The safety and efficacy of the device has not been established.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors. Novocure US operations are based in New York, NY and Portsmouth, NH and the company's research center is located in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
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