On April 30, 2019 Novocure (NASDAQ:NVCR) reported that the International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, has published the results of an EF-14 post-hoc analysis demonstrating that higher doses of Tumor Treating Fields improved survival in newly diagnosed glioblastoma (GBM) patients (Press release, NovoCure, APR 30, 2019, View Source [SID1234535470]). The Red Journal is the official journal of the American Society for Radiation Oncology. This publication is the first reported analysis demonstrating patient-level dose responses to Tumor Treating Fields.
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"The study provides a definition for Tumor Treating Fields dose and creates a framework for Tumor Treating Fields dosimetry and treatment planning," said Matthew T. Ballo, MD, FACR, Professor and Chair, Department of Radiation Oncology, West Cancer Center & Research Institute in Germantown, Tennessee. "This analysis provides radiation oncologists with a better understanding of the relationship between Tumor Treating Fields dose and survival, and can be used to help optimize outcomes for GBM patients."
The simulation-based, post-hoc analysis included 340 patients from the EF-14 phase 3 pivotal trial, which compared Tumor Treating Fields plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM. All EF-14 patients who were on treatment for at least two months and who had MRIs of acceptable quality were included.
The median overall survival and progression free survival were significantly longer when the average dose density in the tumor bed was >0.77 mW/cm3: overall survival (25.2 versus 20.4 months, p=0.003, HR=0.611) and progression free survival (8.5 versus 6.7 months, p=0.02, HR=0.699). For Tumor Treating Fields, dose can be defined as time on therapy times the energy delivered, or cumulative energy.
"With the knowledge gained from this study, we have focused our engineering efforts on evolving our Optune system to improve efficacy and extend survival," said Novocure CEO Asaf Danziger. "We have also developed novel mapping algorithms to optimize treatment planning and are working to incorporate these algorithms into a second generation NovoTAL system. We are excited by the potential of these developments to improve patients’ lives."