FDA grants IDE to NovoCure for phase II Optune trial

NovoCure (NSDQ:NVCR) said today that Radiation Therapy Oncology Group Foundation won FDA investigational device exemption to conduct a Phase II pilot test of NovoCure’s Optune in conjunction with bevacizumab to treat bevacizumab-refractory recurrent glioblastoma.

The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death.

“This is the 1st consortium study of TTFields, representing a growing interest in TTFields therapy from the scientific community. 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,” NovoCure chief science officer Dr. Eilon Kirson said in a press release.

The newly cleared study is slated to enroll 85 patients with a recurrence or progression of glioblastoma or other grade IV glioma after treatment with bevacizumab.

The trial aims to explore the efficacy of TTFields therapy together with bevacizumab, measured by overall survival at 6 months, with additional endpoints of overall and progression-free survival from time of registration, response rates and toxicities of the paired treatment.

“RTOG is excited to partner with NovoCure on this important study, and we are pleased to be able to offer Optune to our patients. 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,” RTOG Foundation chair Dr. Walter Curran of Atlanta, Ga.’s Emory University said in a prepared statement.

In March, NovoCure said it won reimbursement from Humana for treatments with its Optune device for patients with recurrent glioblastoma. The new reimbursement win brings the number of commercial payers covering Optune treatment up to 9, NovoCure said in a press release.

In January, NovoCure said  it applied for a supplemental pre-market approval from the FDA for the 2nd generation of its Optune device for treating glioblastoma, a form of brain cancer.

The FDA approved Optune’s 1st iteration in April 2011. NovoCure said it pared the weight of the newer version, which hit the European market last October, from 6 pounds to 2.7 pounds using digital signal generation technology.

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