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FDA Approves Investigational Device Exemption for RTOG Trial of Novocure’s Optune together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma

ST. HELIER, Jersey, Apr 25, 2016 (BUSINESS WIRE) -- Novocure™ NVCR, +1.03% 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.”

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