NovoCure announced that the first patient has been enrolled in its EF-33 phase 2 pilot trial of Tumor Treating Fields delivered utilizing high-intensity arrays in patients with recurrent glioblastoma (GBM). Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division.
Tumor Treating Fields survival benefit has shown a positive correlation with electric field intensity. The Optune system currently delivers Tumor Treating Fields therapy for the treatment of GBM using four transducer arrays with nine ceramic discs each. To increase field intensity, Novocure designed high-intensity arrays with 14 ceramic discs each for use in the EF-33 study. Increasing the surface area of the array is expected to enable delivery of higher field intensities while maintaining the treatment’s safety profile.
“Building upon a foundation of compelling preclinical and clinical evidence, we continue to expand our product development programs to support our mission to extend survival in some of the most aggressive forms of cancer,” said William Doyle, Novocure’s executive chairman. “We believe we have a considerable opportunity to improve Tumor Treating Fields delivery systems through product innovation and are very pleased to bring the first high-intensity arrays to the clinic. We look forward to sharing data from these programs in future quarters.”
EF-33 is an open-label, single-arm clinical trial to study if Optune delivered at 200 kHz to the brain using high-intensity arrays in the treatment of recurrent GBM significantly improves the clinical outcomes of patients compared to using standard transducer arrays. The study will enroll 25 patients with a minimum follow-up of six months. Patients will remain on Optune until disease progression. The primary endpoint of EF-33 is progression free survival. Secondary endpoints include overall survival, progression free survival rate at six months, overall survival rate at one year and two years, overall radiological response, and severity and frequency of adverse events. All comparisons will be made against historical control data from Novocure’s EF-11 study. Final data from the study is expected in 2022, at which point Novocure will determine the appropriate regulatory pathway for potential commercial use.
Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.