June 5, 2010 (Chicago, IL) – Data from the first phase III clinical trial of NovoCure's NovoTTFdevice for treatment of patients with recurrent glioblastoma (GBM) were presented today as alate breaking abstract during the Neuro-Oncology session at the American Society of ClinicalOncology (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 availablechemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targetedtreatments.
The study enrolled 237 patients with recurrent, late-stage GBM, the most malignant form ofprimary 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 promiseof clinical benefit for the treatment of brain cancer.
"We are continuously researching treatments that offer patients with recurrent glioblastoma abetter quality of life while not compromising potential efficacy or patient safety," said PhilipGutin, M.D., primary investigator for the study; chair of the Department of Neurosurgery, coexecutivedirector of the Brain Tumor Center, and Fred Lebow chair in Neuro-Oncology ofMemorial Sloan-Kettering Cancer Center. "Data from this non-invasive, non-chemotherapyoption are encouraging, and could establish this device as another treatment option for thispopulation."
The randomized, controlled, phase III clinical trial compared NovoTTF monotherapy with thebest available chemotherapy, as determined by the study physicians in the US and Europe, inpatients with recurrent, late-stage GBM. In the intent-to-treat population, patients treated withNovoTTF lived as long as those treated with the best available chemotherapy, includingbevacizumab (median overall survival 6.6 months vs. 6.0 months; p=ns). Overall response rate(complete and partial responses according to investigator assessment using MacdonaldCriteria) 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, whocompleted at least one course of treatment — either NovoTTF treatment or the best availablechemotherapy — NovoTTF patients experienced an increase in median overall survivalcompared 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 toinvestigator assessment using Macdonald Criteria) was much higher in the NovoTTF group thanin the best available chemotherapy group (15.1% vs. 5.1%).
In addition, NovoTTF treatment was associated with 3-4 times fewer infections, and lesshematological and gastrointestinal side effects compared to standard chemotherapy. In theNovoTTF-treated group, mild-to-moderate skin irritation (mainly rash) beneath the deviceelectrodes 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 ofthe device electrodes.
"In the study, NovoTTF proved to be a valid treatment option for cancer patients. The studyshowed that NovoTTF was well tolerated by GBM patients and should be considered areasonable treatment option for recurrent GBM," said Roger Stupp, M.D., of the Department ofNeurosurgery of the University of Lausanne Medical Center (CHUV), Switzerland. Dr. Stupp is aworld renowned leader in glioblastoma research and father of the standard of care "Stuppprotocol" using combined radiotherapy and temozolomide in newly diagnosed GBM patients.
"We're pleased to present the first phase III data for this novel treatment modality, which holdspromise for people with recurrent GBM," said Asaf Danziger, chief executive officer ofNovoCure. "The NovoTTF is approved for sale in Europe. NovoCure is planning to submit apremarket approval application (PMA) to FDA in the near future. We look forward to ourinteractions with the U.S. Food and Drug Administration on the PMA and we are hopeful thatNovoTTF will be made available in the future to U.S. patients."
An ongoing US and European, multi center, phase III study of NovoTTF combined withchemotherapy for the treatment of newly diagnosed GBM was initiated in 2009.
The NovoTTF is an investigational device in the United States and has not been approved byFDA for sale in the US for any use. NovoCure currently has CE Mark for NovoTTF and thetreatment is available to patients in Europe.
Source: Edelman Public Relations