ST. HELIER, JERSEY, 15 December 2015 – Novocure (NASDAQ: NVCR) announced today that data from the pivotal phase 3 clinical trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) have been published in the Journal of the American Medical Association(JAMA). The EF-14 trial results show that Optune plus standard of care temozolomide significantly extended both progression-free survival (PFS) and overall survival (OS) compared with temozolomide alone in the treatment of adults with newly diagnosed GBM. Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields – referred to as Tumor Treating Fields, or TTFields – that inhibit cancer cell replication and cause cancer cell death.
“The EF-14 data are spectacular,” said Roger Stupp, MD, Director of the Department of Oncology and University Hospital Cancer Center at the University of Zurich, Switzerland, and EF-14 Principal Investigator. “They support Tumor Treating Fields as a new standard of care for patients suffering from glioblastoma. These results establish a proof-of-principle of an entirely new cancer treatment modality.”
The U.S. Food and Drug Administration (FDA) approved Optune for the treatment of adults with newly diagnosed GBM in combination with temozolomide on Oct. 5, 2015, based on the EF-14 phase 3 trial results. Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM patients. The FDA previously approved Optune in April 2011 for the treatment of adults with GBM following tumor recurrence after receiving chemotherapy.
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Superiority versus Standard Treatment Halts Trial Early
EF-14 is a large, multinational, open-label, randomized phase 3 trial comparing Optune in combination with temozolomide to temozolomide alone in 700 patients with newly diagnosed GBM. The trial was designed to test both PFS and OS.
In November 2014, the trial’s independent data monitoring committee concluded that the study met its endpoints at its pre-specified interim analysis of the first 315 patients with 18 months or more of follow-up. The committee recommended that the trial be terminated early for success and that all control patients be offered TTFields therapy even prior to progression.
The EF-14 interim analysis reported in JAMA demonstrates that, after a median follow-up of 38 months:
