Optune Combination Improves Survival in Glioblastoma

Newly diagnosed patients with glioblastoma (GBM) saw an improvement in progression-free survival (PFS) and overall survival (OS) when they were given Optune plus temozolomide compared to those who had temozolomide alone, according to results from the phase 3 EF-14 trial that were published in the Journal of the American Medical Association (JAMA).

Optune is a method of treatment where adhesive patches are applied to the patient’s scalp. The patch transductors deliver low-intensity electric fields — called Tumor Treating Fields – that stop the growth and division of GBM cells.

“This is the first positive phase 3 trial in newly diagnosed GBM since the efficacy of temozolomide was demonstrated in 2005,” said Jay-Jouang Zhu, M.D., Ph.D., investigator and director of Neuro-Oncology at UT Health and Memorial Hermann Hospital, MdGovern Medical School in Houston, in a press release.

“The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long-term survival. The results demonstrated that Tumor Treating Fields are an effective antimitotic treatment modality, which could change the way we treat a variety of tumors in the future.”

The multi-national, randomized, open-label trial was conducted across 83 cancer centers and involved a total of 695 patients. The data confirmed and improved upon the results of an interim analysis of the trial that were previously published in 2015.

OS and PFS were both improved by 37 percent for patients who received the combination. While average OS was 16 months for patients treated with temozolomide alone, those who had both temozolomide and Optune experienced an average OS of 20.9 months. Patients who received the combination regimen also showed superior five-year survival rates (13 percent vs. 5 percent) compared with those who were given temozolomide alone — the best results reported for newly diagnosed GBM patients in a phase 3 trial to date, according to the press release.

The OS benefit was observed across all patient subgroups, including those with the worst prognosis who did not have success on other therapies. These patients include those who are 65 years or older and patients with unmethylated MGMT promoter, a prognostic factor in GBM.

The combination produced no increase in systemic adverse events, and the only common side effect from Optune was mild to moderate skin irritation beneath the system’s transductor arrays.

Optune is intended to treat patients who are 22 years of age or older with histologically-confirmed GBM. The agent is currently approved to treat patients who have supratentorial GBM following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy; and to treat patients with recurrent GBM following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. Of note, the device is intended to be used as a monotherapy, and as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Used as a monotherapy, Optune is intended as an alternative to standard therapy after surgical and radiation options have been exhausted.

“GBM is a very difficult to treat disease where over 20 large randomized phase 3 studies have failed to show a survival benefit over the past decade. We are proud of the EF-14 final analysis and what it means to patients living with GBM,” said Asaf Danziger, CEO of Novocure, the company that makes Optune. “We are honored to have the final analysis published in such a prestigious medical journal and believe it will help us to continue to effectively educate the medical community about the benefits of Optune with temozolomide for the treatment of newly diagnosed GBM.”

Optune is also being explored for the treatment of brain metastases, non-small cell lung cancer (NSCLC), pancreatic cancer, ovarian cancer and mesothelioma.