More data is now coming in from a phase III randomized clinical trial in patients with recurrent glioblastoma treated with NovoCure‘s NovoTTF-100A device. As was reported here before, NovoTTF-100A is a portable, battery operated device that produces low intensity alternating electric fields (TTFields) delivered through electrodes attached to the scalp, that disrupt cancer cell proliferation and tumor growth, probably by inhibiting mitosis. The latest results from 237 patients randomized at 28 centers in USA & Europe were presented at the Society for Neuro-Oncology (SNO) Annual Scientific Meeting, and here’s what a representative for the company tells Medgadget:
The results reported expand on top-line data presented at ASCO in June 2010, which suggested that TTF therapy is as effective as the best available chemotherapy in extending overall survival of patients with recurrent GBM.
In this presentation physicians delivered the investigational TTF therapy to patients in the study using the NovoTTF-100A – a portable, non-invasive medical device. Investigators conducted this phase III study at 28 centers in the US, Europe, and Israel, enrolling 237 patients with glioblastoma tumors that had recurred or progressed after initial treatment. Patients randomly received TTF therapy alone or an effective chemotherapy selected by physicians. Patients under the age of 60 who were able to maintain normal daily activities (KPS>80 percent) at the time of enrollment achieved a significant increase in median overall survival time (8.8 vs. 6.6 months, n=110, p<0.01) and in the 1-year survival rate (35 percent vs. 20 percent, n=110, p<0.01) when treated with TTF Therapy versus effective chemotherapies.
The device is currently approved in Europe to treat glioblastoma, the most malignant form of brain cancer. The company has also filed with the FDA for approval in that indication in the U.S. Of note, the device also recently demonstrated efficacy in patients with non-small cell lung cancer. Data from a phase II study in NSCLC was presented at European Society of Medical Oncology (ESMO) last month. The data show that patients with advanced NSCLC achieved a significant increase in survival time when the device was used in combination with traditional chemotherapy, compared to previously reported outcomes for patients receiving chemotherapy alone.
Abstract: Subgroup and quality of life analyses of the phase III clinical trial of NovoTTF-100A versus best standard chemotherapy for recurrent glioblastoma
More from the press release: Professor Zvi Ram presents phase III recurrent glioblastoma survival and quality of life data from the first pivotal study of the NovoTTF-100A at 15th Annual Society for Neuro-Oncology Scientific Meeting …
Flashbacks: NovoTTF as Effective as Chemotherapy for Recurrent Glioblastoma; NovoTTF-100A for Glioblastoma Multiforme