10 December 2018 - - The results of a retrospective post-hoc sub-group analysis of Jersey-based Novocure's (NASDAQ: NVCR)
EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma have been published in the Journal of Neuro-Oncology, the company said.

The analysis demonstrated that more time on Optune predicted increased survival in patients who received Optune plus temozolomide compared to patients who received temozolomide alone.

Optune is a noninvasive, portable medical device that delivers Tumor Treating Fields to people with GBM.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing certain cancer cells to die.

Data from this sub-group analysis demonstrated that patients using Optune 50% or more of the time had a survival benefit compared to those who used temozolomide alone (n=388/450, OS HR 0.67, 95% CI 0.45–0.99).

Patients who used Optune more than 90% of the time experienced a median overall survival of 24.9 months (n=43; OS HR 0.52, 95 % CI 0.35–0.79) and a predicted 5-year survival rate of 29.3% versus a median overall survival of 16.0 months and a predicted 5-year survival rate of 4.5% for patients who used temozolomide alone.

Monthly usage was a predictor of survival, independent of other prognostic factors such as Karnofsky Performance Status, age or MGMT methylation status.

Novocure's phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in a total of 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival and overall survival.

The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM for those patients treated with Optune in combination with temozolomide.

Those patients experienced an extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain their mental, emotional and physical well-being longer than those treated with temozolomide alone, as measured for up to one year.

Novocure is an oncology company developing a profoundly different cancer treatment utilising a proprietary therapy called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure's commercialized product is approved for the treatment of adult patients with glioblastoma.

Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and mesothelioma.

Headquartered in Jersey, Novocure has US operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel.