FDA Approves Second-Generation Optune System for GBM

The FDA has approved a lighter and more convenient version of the Optune system for patients with glioblastoma multiforme.

The new version of Optune, which is carried by the patient throughout their daily activities, weighs 2.7 pounds and is easier to transport. The previous version weighed 6 pounds. Patients using the first-generation of the device will be given the opportunity to switch to the newly approved version within the next few weeks.

“We are happy to receive FDA approval of our second generation Optune system,” Asaf Danziger, chief executive officer at Novocure, said in a statement. “We believe the improvements incorporated into the second-generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience.”

The first-generation of Optune was most recently approved in 2015 for use in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation therapy. Optune was initially approved in 2011 for the treatment of recurrent GBM after other surgical and radiation options were exhausted.

The lighter, second-generation Optune device has been used in Germany since October 2015. The design changes made to the system were meant to improve patient experience and power source management, via displays and alerts when batteries needed to be changed. Additionally, batteries can be changed in the new device without stopping or interfering with treatment.

“The second-generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives," said Mike Ambrogi, Novocure’s Chief Operating Officer. "We have received positive feedback from our second-generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”

In the adjuvant setting, Optune demonstrated an improvement in overall survival (OS) when combined with temozolomide, when compared with the chemotherapy agent alone. In an analysis of 695 patients enrolled in the phase III EF-14 study, the median OS was 19.4 months with Optune compared with 16.6 months with temozolomide alone. Additionally, progression-free survival (PFS) was improved by approximately 3 months, according to the FDA.

For the full population of the study (N = 700) with longer follow-up, the 24-month OS rate with Optune in combination with temozolomide was 48% compared with 32% with monotherapy (P= .0058). The median PFS was 7.2 versus 4.0 months with the combination and single-agent, respectively (HR, 0.62;P= .001). The median OS was 20.5 months with Optune compared with 15.6 months (HR, 0.66;P= .004).

Adverse events (AEs) were similar between the arms and were primarily associated with temozolomide. The most common AEs related to Optune were skin irritation, which occurred in 45% of patients utilizing the device. As a precaution, the FDA advised against using the device in patients with an active implanted medical device, a skull defect, or a known sensitivity to conductive hydrogels.

Clinical trials continue to assess Optune in various combinations for patients with brain cancer, including a phase II study exploring the treatment in combination with bevacizumab and temozolomide for unresectable GBM (NCT02343549). Optune is also being explored in earlier settings in combination with bevacizumab and hypofractionated stereotactic irradiation in bevacizumab-naive patients with recurrent GBM (NCT01925573).