On December 6, 2018 Novocure (NASDAQ:NVCR) reported that the results of a retrospective post-hoc sub-group analysis of its EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma (GBM) have been published in the Journal of Neuro-Oncology (Press release, NovoCure, DEC 6, 2018, View Source [SID1234531931]). The analysis demonstrated that more time on Optune predicted increased survival in patients who received Optune plus temozolomide compared to patients who received temozolomide alone. Optune is a noninvasive, portable medical device that delivers Tumor Treating Fields to people with GBM. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing certain cancer cells to die.
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"The total amount of time the device is worn, also known as monthly Optune usage – or treatment compliance – matters greatly for patients with GBM, one of the most aggressive forms of cancer," said Steven A. Toms, MD, Professor of Neurosurgery and Medicine, and Vice Chair of the Department of Neurosurgery at Lifespan Health System, and the Warren Alpert Medical School of Brown University in Providence, Rhode Island, and author of the article. "Optune plus temozolomide has proven to provide long-term quality survival to patients with newly diagnosed GBM. Therefore, the importance of monthly Optune usage should be reinforced with patients by their health care providers."
Data from this sub-group analysis demonstrated that patients using Optune 50 percent or more of the time had a survival benefit compared to those who used temozolomide alone (n=388/450, OS HR 0.67, 95% CI 0.45–0.99). Patients who used Optune more than 90 percent of the time experienced a median overall survival of 24.9 months (n=43; OS HR 0.52, 95 percent CI 0.35–0.79) and a predicted 5-year survival rate of 29.3 percent versus a median overall survival of 16.0 months and a predicted 5-year survival rate of 4.5 percent for patients who used temozolomide alone. Monthly usage was a predictor of survival, independent of other prognostic factors such as Karnofsky Performance Status, age or MGMT methylation status.
Novocure’s phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in a total of 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival and overall survival. The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM for those patients treated with Optune in combination with temozolomide. Those patients experienced an extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain their mental, emotional and physical well-being longer than those treated with temozolomide alone, as measured for up to one year.