FDA Approves Investigational Device Exemption for RTOG Trial of Novocure's Optune together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma
Novocure™ (NASDAQ: NVCR) announced today that the RTOG Foundation will conduct a phase 2 pilot trial testing Optune together with bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma (GBM). The RTOG Foundation recently received an investigational device exemption (IDE) from the U.S. Food and Drug Administration for the trial protocol.
Optune is an FDA-approved portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma. In recurrent glioblastoma, both TTFields and bevacizumab are approved as monotherapies. The current trial intends to test the efficacy and safety of TTFields in combination with bevacizumab.
The RTOG Foundation Study RTOG 3503 will include 85 patients at 20 institutions nationwide. Patients must have a recurrence or progression of glioblastoma or other grade IV glioma after being treated with bevacizumab. The trial will determine the efficacy of TTFields therapy together with bevacizumab measured by overall survival (OS) at six months. Additional endpoints include overall and progression-free survival (PFS) from time of registration, response rates, and toxicities of bevacizumab with TTFields therapy.
"This is the first consortium study of TTFields, representing a growing interest in TTFields therapy from the scientific community," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We are excited that the RTOG is researching the potential benefit of TTFields therapy together with bevacizumab in this difficult-to-treat population of patients. A post hoc analysis of the EF-14 phase 3 trial in newly diagnosed glioblastoma patients suggested that adding TTFields to chemotherapy or bevacizumab after disease progression may extend overall survival. The RTOG trial will test this finding prospectively in a subgroup of recurrent GBM patients who have a very poor prognosis."
"RTOG is excited to partner with Novocure on this important study, and we are pleased to be able to offer Optune to our patients," said Dr. Walter J. Curran, RTOG Foundation Chairman and Executive Director of the Winship Cancer Institute of Emory University in Atlanta. "The results of this trial will provide additional information to the brain tumor research community on the safety and effectiveness of using Optune in combination with bevacizumab in patients with bevacizumab-refractory recurrent GBM. These patients face a dismal prognosis and are in need of treatment options."
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.
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
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 four 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.
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 US or by email at supportEMEA@novocure.com in the European Union.
About the RTOG Foundation
The RTOG Foundation, Inc., a nonprofit research organization, is an international leader in conducting practice-changing clinical trials involving advanced radiotherapy techniques and their combination with new classes of anti-cancer biomarker driven therapies. RTOG Foundation is the successor to the Radiation Therapy Oncology Group, a 40-year participant in the NCI-funded cooperative group program. RTOG's mission then and now is to improve the survival and quality of life of cancer patients. RTOG trials employ translational research strategies to identify patient subgroups that are at risk for failure with existing treatments and identify new treatment options for these patients. RTOG designs and conducts NCI-funded trials as a founding member of NRG Oncology and collaborates with industry partners to identify and test promising new agents through multisite private sector trials.
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure's U.S. operations are based in Portsmouth, New Hampshire, and New York City. 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.
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