Novocure (NASDAQ:NVCR) announced today that the first patient has
been enrolled in the METIS trial, a phase 3 pivotal trial studying
radiosurgery plus Tumor Treating Fields (TTFields) compared to
radiosurgery alone for the treatment of brain metastases from
non-small cell lung cancer (NSCLC). METIS is Novocure’s first phase
3 pivotal trial outside of glioblastoma.
“We have a clear, unmet need for an effective
treatment for brain metastasis, a devastating, prevalent
condition,” said Dr. Minesh P. Mehta, Deputy Director and Chief of
Radiation Oncology at Miami Cancer Institute at Baptist Health
South Florida. “Existing treatments often cause significant
neurological deterioration or do not prevent brain metastases from
recurring. Based on the company’s pre-clinical research showing
TTFields can prevent metastatic seeding in vivo and the established
safety and efficacy of TTFields in glioblastoma, there is a strong
scientific rationale for studying TTFields as a potential brain
metastases treatment.”
The multicenter, open-label study will include 270
patients with 1 to 10 brain metastases who will be randomized 1:1
to receive, following radiosurgery, either TTFields at a frequency
of 150kHz plus supportive care or supportive care alone. The
primary endpoint is time to first cerebral progression. Secondary
endpoints include time to neurocognitive failure, overall survival
and radiological response rate.
“We are happy to enroll the first patient in the
METIS trial,” said Dr. Nicholas A. Blondin, Neuro-Oncology Program
Director at Associated Neurologists of Southern Connecticut, in
Fairfield, Connecticut. “Brain metastases patients deserve more
treatment options, and this trial will assess the efficacy and
safety of TTFields in the treatment of brain metastases.”
TTFields is a low-toxicity anti-mitotic treatment
that uses low-intensity, intermediate frequency, alternating
electric fields to exert physical forces on key molecules inside
cancer cells, disrupting the basic machinery necessary for normal
cell division, leading to cancer cell death.
“We are excited to start the METIS trial and are
working to diligently enroll patients,” said Dr. Eilon Kirson,
Chief Science Officer and Head of Research and Development at
Novocure. “NSCLC patients with brain metastases suffer not only
from their primary disease in the lungs, but also from the risk of
neurocognitive deterioration due to the recurrence of brain
metastases or neurotoxic treatments. We believe TTFields has the
potential be an effective treatment option to prevent the
appearance of new brain metastases without causing additional
neurotoxicity.”
About Brain MetastasesMetastatic
cancer is cancer that has spread from the place where it first
started to another place in the body. The exact incidence of brain
metastases originating from non-small cell lung cancer is unknown
because no national cancer registry documents brain
metastases. It has been estimated that 98,000 to 170,000 new
cases of brain metastases are diagnosed in the United States each
year and, of those, the Company estimates that 40 percent originate
from non-small cell lung cancer.
Tumor Treating Fields (TTFields) is not indicated
for the treatment of brain metastases and is currently available
for investigational use only in the United States.
About NovocureNovocure is a
commercial-stage oncology company developing a novel, proprietary
therapy called Tumor Treating Fields, or TTFields, for the
treatment of solid tumor cancers. Novocure’s commercialized
product, Optune, is approved for the treatment of adult patients
with glioblastoma. Novocure has ongoing or completed phase 2 pilot
trials investigating TTFields in NSCLC, pancreatic cancer, ovarian
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 and Japan, and a research center in Haifa, Israel. For
additional information about the company, please visit
www.novocure.com or follow us at
www.twitter.com/novocure.
Approved Indications In the United
States, Optune is intended as a treatment for adult patients (22
years of age or older) with histologically-confirmed glioblastoma
multiforme (GBM).
In the United States, 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.
In the United States, 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.
In the European Union, Optune is intended for the
treatment of patients with newly diagnosed GBM, after surgery and
radiotherapy with adjuvant temozolomide, concomitant to maintenance
temozolomide. The treatment is intended for adult patients, 18
years of age or older, and should be started more than four weeks
after surgery and radiation therapy with adjuvant temozolomide.
Treatment may be given together with maintenance temozolomide and
after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for
the treatment of patients with recurrent GBM who have progressed
after surgery, radiotherapy and temozolomide treatment for their
primary disease. The treatment is intended for adult patients, 18
years of age or older, and should be started more than 4 weeks
after the latest surgery, radiation therapy or chemotherapy.
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
in the US or by email at supportEMEA@novocure.com in the
European Union.
Forward-Looking StatementsIn
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,
development of potential products, interpretation of clinical
results, prospects for regulatory approval, manufacturing
development and capabilities, market prospects for its products,
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 March 1, 2016,
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.
Media and Investor Contact
Ashley Cordova, Novocure
acordova@novocure.com
212.767.7558
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