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Successful Phase III Clinical Trial Results Reported For NovoCure's Novel Medical Device For Treatment Of Recurrent Glioblastoma



Data from the first phase III clinical trial of NovoCure's NovoTTF device for treatment of patients with recurrent glioblastoma (GBM) were presented as a late breaking abstract during the Neuro-Oncology session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Study results show that NovoTTF, a novel, noninvasive, portable medical device, may be as or more effective than the best available chemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targeted treatments.

The study enrolled 237 patients with recurrent, late-stage GBM, the most malignant form of primary brain cancer. Using low intensity, alternating electric fields to disrupt tumor growth, NovoTTF is the first non-drug, non-radiation, non-surgical treatment approach to show promise of clinical benefit for the treatment of brain cancer.

"We are continuously researching treatments that offer patients with recurrent glioblastoma a better quality of life while not compromising potential efficacy or patient safety," said Philip Gutin, M.D., primary investigator for the study; chair of the Department of Neurosurgery, coexecutive director of the Brain Tumor Center, and Fred Lebow chair in Neuro-Oncology of Memorial Sloan-Kettering Cancer Center. "Data from this non-invasive, non-chemotherapy option are encouraging, and could establish this device as another treatment option for this population."

The randomized, controlled, phase III clinical trial compared NovoTTF monotherapy with the best available chemotherapy, as determined by the study physicians in the US and Europe, in patients with recurrent, late-stage GBM. In the intent-to-treat population, patients treated with NovoTTF lived as long as those treated with the best available chemotherapy, including bevacizumab (median overall survival 6.6 months vs. 6.0 months; p=ns). Overall response rate (complete and partial responses according to investigator assessment using Macdonald Criteria) was higher for NovoTTF compared with chemotherapy (11.7% vs. 5.9%).

In a per-protocol population, which included approximately 80% of patients in the trial, who completed at least one course of treatment - either NovoTTF treatment or the best available chemotherapy - NovoTTF patients experienced an increase in median overall survival Strictly embargoed until 8:00 A.M. ET, Saturday, June 5, 2010 2 compared with the best available chemotherapy (7.8 months vs. 6.1 months; 28% increase; p<0.05). In this group, overall response rate (complete and partial responses according to investigator assessment using Macdonald Criteria) was much higher in the NovoTTF group than in the best available chemotherapy group (15.1% vs. 5.1%).

In addition, NovoTTF treatment was associated with 3-4 times fewer infections, and less hematological and gastrointestinal side effects compared to standard chemotherapy. In the NovoTTF-treated group, mild-to-moderate skin irritation (mainly rash) beneath the device electrodes was the most frequent treatment-related adverse event (less than 20% of patients). Skin irritation was generally resolved using topical corticosteroids and by periodic relocation of the device electrodes.



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