On October 23, 2018 Novocure (NASDAQ: NVCR) reported that results from a post-hoc analysis of Novocure’s EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma (GBM) that demonstrated that a higher dose of Tumor Treating Fields delivered to the tumor bed was associated with improved overall survival (Press release, NovoCure, OCT 23, 2018, View Source [SID1234530074]). For Tumor Treating Fields, the term delivered dose is a function of power loss density, a measure of energy, and compliance, or monthly usage of therapy. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. The analysis was presented today at the American Society for Radiation Oncology (ASTRO) 2018 Annual Meeting in San Antonio, Texas.
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"This post-hoc analysis of EF-14 is extremely valuable to the radiation oncology community and supports the importance of targeting the tumor of each patient when planning treatment with Tumor Treating Fields," said Matt Ballo, MD, FACR, Director of Radiation Oncology at West Cancer Center in Germantown, Tennessee. "I believe an increased understanding of delivered dose will allow our treatment planning to become more sophisticated over time and help us achieve better patient outcomes."
The post-hoc analysis used patient data from the Tumor Treating Fields treatment arm of Novocure’s EF-14 phase 3 pivotal trial and included only patients who were treated for more than two months to ensure sufficient treatment duration to reach tumor stabilization and for whom quality MRI data was available. Of the 466 patients in the Tumor Treating Fields treatment arm, 379 received therapy for more than two months, and 317 of these patients had sufficient MRI quality to build head models. For each of these 317 patients, an individualized electric field distribution model within the head was created. Transducer arrays were placed on each model and simulations were run to calculate both electric field intensity and power loss density within the tumor bed. Electric field intensity measures the force acting on charges within a region of treatment and power loss density measures the amount of energy at the tumor bed. Power loss density at the tumor bed is a factor of both electric field intensity and tissue conductivity within the region of treatment.
Higher electric field intensity (≥1.0 Volts/cm) and higher power loss density (≥1.1 mW/cm3) at the tumor bed were both associated with improved overall survivals, independent of compliance, or monthly usage of therapy. Power loss density was the most significant driver with a median overall survival of 25.23 months for patients treated with Tumor Treating Fields at power loss densities greater than or equal to 1.1 mW/cm3 (n=122), compared to a median overall survival of 21 months (n=195) for patients treated with Tumor Treating Fields at power loss densities less than 1.1 mW/cm3 (HR, 0.59; 95 percent Cl, 0.43-0.81; P<.01).
A previously presented analysis of EF-14 data demonstrated that more time on Optune predicted an increased survival benefit in patients with newly diagnosed GBM. In the analysis presented today, the greatest improvement in median overall survival among all sub groups was seen in patients who both spent more time on Optune and received Tumor Treating Fields at higher power loss densities. Patients who used Optune more than 85 percent (n=36) of the time and received Tumor Treating Fields at power loss densities greater than or equal to 1.1 mW/cm3 had the greatest improvements in overall survival. Tumor Treating Fields delivered dose can now be defined as a factor of both power loss density and monthly usage of therapy.
"This analysis demonstrated a dose dependence on the overall survival of GBM patients treated with Tumor treating Fields and that improvements in overall survival were possible when patients received an increased delivered dose of Tumor Treating Fields," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "The NovoTAL System is available to help physicians optimize and individualize treatment planning for patients by directing electric field intensity to the region of active tumor. We are committed to further developing our technology and believe increasing the power loss density of Tumor Treating Fields at the tumor bed through treatment planning has the potential to improve patient outcomes."