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
Company Website:
http://www.novocure.com
ST. HELIER, Jersey -- (Business Wire)
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181023006144/en/
Contacts:
Media and Investor Contact:
Novocure
Ashley Cordova,
212-767-7558
acordova@novocure.com
Source: Novocure
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