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Novocure Announces First Analysis of Full 700 Patient Dataset from Successful Newly Diagnosed GBM Phase III Trial

Al's Comment:

 This confirms the good results they reported in the interim analysis a few months ago. 2 year survival for newly diagnosed GBM patients went up from 29%  in the standard therapy group to 43% in the standard + Novocure group.  More of the details will come out on June 2, 2015.  When I discussed the interim results with neuro-oncs , many took the cautious viewpoint of "wait for the full results - it can't be that good".  Well - these are the full results and almost as good as the interim results.  They also had concern that perhaps a major difference in prognostic factors between the control group and treatment group might account for the difference. Hopefully we will find out in a few days when more details are released. 


Posted on: 05/31/2015

 
 
Novocure Alert Service
 
28 May 2015
Novocure Announces First Analysis of Full 700 Patient Dataset from Successful Newly Diagnosed GBM Phase III Trial
 
Full dataset analysis confirms study met its endpoints, extending both progression-free and overall survival of newly diagnosed GBMin the inter patients
 
Analysis will be presented on June 2, 2015 by Roger Stupp, MD at the 2015 Meeting of the American Society of Clinical Oncology in Chicago
 
St. Helier, Jersey – May 28, 2015 – Novocure, a commercial stage oncology company, announced today that the first analysis of all 700 newly diagnosed glioblastoma (GBM) patients enrolled in its EF-14 Phase III 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, Illinois 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% (95% confidence interval 36-50%) compared to 29% (95% confidence interval 21-38%) when treated with temozolomide alone.
    Patients treated with TTFields together with temozolomide demonstrated a significant increase in progression free survival 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 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 Dr. Roger Stupp, M.D., Director of the Department of Oncology and University Hospital Cancer Center at the University of Zurich, Switzerland and EF-14 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 US FDA to make TTFields therapy available to newly diagnosed glioblastoma patients,” said Asaf Danziger, Novocure’s Chief Executive Officer. “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.”
 
About Glioblastoma
Glioblastoma (GBM) is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the US.  Overall survival with standard of care temozolomide chemotherapy alone is approximately 15 months.
 
About Tumor Treating Fields Therapy
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, the process by which cells divide and replicate. 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.
 
Approved Indication
The US 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. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
 
About Novocure
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US 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. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

 


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