New Phase III Data Show Optune in Combination With Second-Line Chemotherapy is Superior

Novocure recently announced new Phase III data showing that glioblastoma patients who received TTFields in combination with chemotherapy at first recurrence lived significantly longer than patients who received chemotherapy alone. The data was presented at the 20th Annual Society for Neuro-Oncology Meeting in San Antonio.

This survival benefit is maintained across multiple lines of second-line therapy, including bevacizumab, and points to the need for physicians to incorporate Optune into the standard-of-care for glioblastoma.

The post-hoc analysis of the EF-14 Phase III clinical trial shows that patients treated with TTFields in combination with physician’s best choice second-line chemotherapy reduced their risk of death by 31% compared to patients treated with physician’s best choice second-line chemotherapy alone (HR= 0.695, p= 0.0489). Patients treated with TTFields in combination with bevacizumab (Avastin), reduced their risk of death by 39% compared to patients treated with bevacizumab alone (HR=0.606, p= 0.0428).

“Our analysis shows that GBM patients continue benefiting from TTFields therapy even after their disease has recurred,” says Santosh Kesari, a trial investigator and Chair of Translational Neuro-Oncology and Neurotherapeutics at John Wayne Cancer Institute and Director of Neuro-Oncology at the Pacific Brain Tumor Center at Providence Saint John’s Health Center in Santa Monica, California. “This survival benefit is maintained across multiple lines of second-line therapy, including bevacizumab, and points to the need for physicians to incorporate Optune into the standard-of-care for glioblastoma.”

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. 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 US, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically confirmed glioblastoma multiforme (GBM). In the US, 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 US, for the treatment of recurrent GBM, Optune is indicated 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 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 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.

In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy 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 US or by email at supportEMEA@novocure.com in the European Union.

Novocure is a 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 more information visit www.novocure.com or follow us at www.twitter.com/novocure.