Post-hoc analysis of EF-14 phase 3 pivotal trial demonstrated that power loss density and electric field intensity were associated with improved overall survival, independent of compliance
This is the first analysis to quantify the delivered dose of Tumor Treating Fields, defined as a function of both power loss density and monthly usage of therapy
Patients who used Optune more than 85 percent 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
Novocure (NASDAQ: NVCR) announced today 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. 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.
"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."
About Novocure
Novocure is an oncology company developing a profoundly different cancer treatment utilizing 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 U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Important Safety Information
Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure (the device manufacturer).
Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.
The most common (=10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.
The most common (=10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.
Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.
Patients should only use Optune under the supervision of a physician properly trained in use of the device.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory submission and approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2018, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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