PFS, OS extended in GBM

Novocure announces first analysis of full 700 patient dataset from newly diagnosed GBM Phase 3 trial

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ST. HELIER, Jersey—Novocure, a commercial stage oncology company, has reported that the first analysis of all 700 newly diagnosed glioblastoma (GBM) patients enrolled in its EF-14 Phase 3 trial confirms that Tumor Treating Fields (TTFields) delivered in combination with standard-of-care temozolomide chemotherapy extends both progression-free survival (PFS) and overall survival (OS) compared to temozolomide alone in patients with newly diagnosed GBM. The full dataset analysis will be presented on June 2 at the 2015 Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Dr. Roger Stupp, professor and chairman, Department of Oncology and director, University Hospital Cancer Center, University of Zurich, Zurich, Switzerland.
A pre-specified, interim analysis of EF-14 trial data conducted on the first 315 patients concluded that the trial met its endpoints of superior progression free and overall survival. The analysis of the full trial cohort of 700 patients confirms these conclusions. The results of the analysis of the full trial cohort show that: The percentage of patients alive at two years when treated with TTFields together with temozolomide was 43 percent (95 percent confidence interval 36-50 percent) compared to 29 percent (95 percent confidence interval 21-38 percent) when treated with temozolomide alone.
Further, patients treated with TTFields together with temozolomide demonstrated a significant increase in PFS compared to temozolomide alone (median PFS of 7.1 months compared to 4.2 months, hazard ratio=0.69, p=0.001). Patients treated with TTFields together with temozolomide also demonstrated a significant increase in overall survival compared to temozolomide alone (median OS from randomization of 19.4 months compared to 16.6 months, hazard ratio=0.75, p=0.022).
“We are pleased that the first analysis of the full 700 patient cohort confirms the findings of the interim analysis,” said Stupp, the study’s principal investigator. “After ten years of research, this novel treatment represents a long-awaited breakthrough in the treatment of this aggressive and deadly disease. Many patients will gain additional quality time and it offers new hope.”
“Novocure is committed to the development of TTFields therapy for a variety of solid tumor cancer types,” said William Doyle, executive chairman of Novocure. “The results presented by Dr. Roger Stupp demonstrate the potential for establishing TTFields as a major new modality for solid tumor cancer treatment.”
“We continue to work closely with the U.S. FDA to make TTFields therapy available to newly diagnosed glioblastoma patients,” said Asaf Danziger, Novocure’s CEO. “The FDA recently granted priority review status for Novocure’s PMA supplement application. We are hopeful this will lead to expansion of our approved indication to include newly diagnosed glioblastoma in addition to recurrent glioblastoma during the second half of this year.”
Glioblastoma (GBM) is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the U.S. Overall survival with standard of care temozolomide chemotherapy alone is approximately 15 months.
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In-vitro and in-vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis of cancer cells. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
The U.S. Food and Drug Administration (FDA) has approved the TTFields therapy delivery system, Optune (previously known as the NovoTTF-100A System), for use as a treatment for adult patients (22 years of age or older) with histologically confirmed GBM, following histologically or radiologically confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. Patients should only use Optune under the supervision of a physician properly trained in use of the device.
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel.

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