Novocure touts results from glioblastoma TTF trial analysis

NovoCure (NSDQ:NVCR) yesterday released results from a post-hoc analysis of its EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma, touting an association between higher doses of Tumor Treating Fields and improved overall survival.

The analysis explored patient data from 317 qualified individuals in the TTF treatment arm of the St. Helier, Jersey-based company’s EF-14 phase 3 pivotal trial, including only patients who were treated for more than two months to guarantee appropriate treatment duration for stabilization and those with quality MRI data.

“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. 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,” Dr. Matt Ballo of the Germantown, Tenn.-based West Cancer Center said in a press release.

For each patient analyzed, individualized electric field distribution models within the head were created. Transducer arrays were placed on the models and simulations were run to calculate both electric field intensity and power loss density within the tumor bed.

Both higher electric field intensity and higher power loss density at the tumor bed were found to be associated with improved overall survival rate, independent of compliance or monthly usage of therapy. The most significant driver was power loss density, with a reported median overall survival of approximately 25.2 months for patients treated with TTF at power loss densities greater than or equal to 1.1 mW/cm3 as compared to median overall survival.

NovoCure said that the greatest improvement in median overall survival among all subgroups was seen in patients who both spent more time receiving TTF therapy and did so on higher power loss densities.

“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. 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,” Novocure chief science officer Dr. Eilon Kirson said in a prepared statement.

Earlier this month, Novocure said that the durable medical equipment Medicare Administrative Contractors accepted a new local coverage determination reconsideration request for the treatment of newly diagnosed glioblastoma with its Optune system.

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