Novocure to Present the Latest Data from the EF-14 Clinical Trial in Newly Diagnosed GBM at the 15th Interim Meeting of the World Federation of Neurosurgical Societies
Novocure, a commercial stage oncology company, announced today that the latest data from the EF-14 randomized phase 3 trial of Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma (GBM) will be presented by Professor Zvi Ram, Head of the Department of Neurosurgery, Tel Aviv Medical Center, Israel, in an oral session at the 15th Interim Meeting of the World Federation of Neurological Societies (WFNS). The WFNS is a professional, scientific, non-governmental organization comprising of 127 member societies representing over 30,000 neurosurgeons worldwide. The 15th Interim meeting of the WFNS will be held in Rome, Italy on September 8-12, 2015.
The presentation by Professor Ram will include the latest efficacy and safety data from the EF-14 trial and will also discuss emerging data on the possible molecular pathways involved in the effect of TTFields in GBM. The data presented provide further evidence in support of the following findings of the EF-14 interim analysis:
- The two-year survival rate among patients treated with TTFields in combination with temozolomide, in the as treated population, was 48% compared to 32% among patients treated with temozolomide alone (p=0.0058);
- Patients treated with TTFields, in combination with temozolomide, in the intent-to-treat population, demonstrated a statistically significant increase in PFS compared to temozolomide alone (median PFS of 7.2 months compared to 4.0 months, hazard ratio=0.62, p=0.001); and
- Patients treated with TTFields, in combination with temozolomide, in the as-treated population, demonstrated a statistically significant increase in OS compared to temozolomide alone (median OS of 20.5 months compared to 15.6 months, hazard ratio=0.66, p=0.004).
"The latest efficacy and safety data continue to demonstrate statistically significant survival benefits in newly diagnosed GBM patients treated with TTFields. We are also discovering additional molecular mechanisms that play a part in this treatment modality. I believe these mechanisms may enable a more targeted and effective therapeutic effect in GBM and other solid cancers," said Professor Zvi Ram. "I believe TTFields will become a part of the standard treatment for patients diagnosed with GBM."
"We are excited to see the interest this data are generating in the scientific community," said Eilon Kirson, MD, PhD, Chief Science Officer and Head of Research and Development at Novocure. "We hope that with better understanding of the underlying molecular mechanisms of the effect of TTFields, future developments will lead to even better outcomes in patients treated with this novel treatment modality."
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.
TTFields therapy is experimental in the United States for the treatment of newly diagnosed GBM. Limited by law to investigational use only
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.
In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
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 Germany, 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.
Media and Investor:
Ashley Cordova, 212-767-7558