The RTOG 3503 phase 2 pilot trial is the first consortium study to
test treatment with Optune
ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure™ (NASDAQ: NVCR) announced today that the first patient has been
enrolled in the RTOG Foundation’s phase 2 pilot trial testing Optune
together with bevacizumab for patients with bevacizumab-refractory
recurrent glioblastoma (GBM).
Optune is an FDA-approved Tumor Treating Fields (TTFields) delivery
system for the treatment of newly diagnosed and recurrent GBM. In
recurrent GBM, both Optune and bevacizumab are approved as
monotherapies. The current trial intends to test the efficacy and safety
of Optune in combination with bevacizumab for the treatment of patients
with bevacizumab-refractory recurrent GBM.
“The results of this trial will provide additional information to the
brain tumor research community on the safety and effectiveness of using
Optune in combination with bevacizumab in patients with
bevacizumab-refractory recurrent GBM,” said Dr. Manmeet Ahluwalia, Dean
and Diane Miller Endowed Chair in NeuroOncology at Cleveland Clinic and
Co-Principal Investigator of the trial. “These patients face a dismal
prognosis and are in need of treatment options.”
The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at
20 institutions in the United States. Patients must have a recurrence or
progression of GBM or other grade IV glioma after being treated with
bevacizumab. The trial will determine the efficacy of Optune together
with bevacizumab measured by overall survival at six months. Additional
endpoints include overall and progression-free survival from time of
registration, response rates, and toxicities of bevacizumab with Optune.
“This is the first consortium study of TTFields, demonstrating the
continued and mounting interest in Optune from the scientific
community,” said Dr. Eilon Kirson, Chief Science Officer and Head of
Research and Development at Novocure. “Our EF-11 phase 3 pivotal trial
in recurrent GBM patients suggested that in a subgroup of patients who
were refractory to bevacizumab Optune monotherapy led to an extension in
survival versus chemotherapy. We are excited that RTOG is researching
the potential benefit of Optune together with bevacizumab in this
difficult-to-treat population of patients.”
“For 40 years, RTOG has conducted studies designed to improve the
survival and quality of life of cancer patients,” said Dr. Jeffrey J.
Raizer, Co-Founding-Director of the Northwestern Brain Tumor Institute
and Co-Principal Investigator of the trial. “RTOG is excited to partner
with Novocure on this important study, and I am pleased to be able to
offer Optune to patients in this study.”
For more information on the trial designs, visit clinicaltrials.gov and
reference NCT02743078.
Treatment with TTFields is not approved in combination with bevacizumab
for the treatment of patients with bevacizumab-refractory recurrent GBM
by the U.S. Food and Drug Administration. The safety and effectiveness
of TTFields in combination with bevacizumab for the treatment of
patients with bevacizumab-refractory recurrent GBM has not been
established.
About the RTOG Foundation
The RTOG Foundation, Inc., a nonprofit research organization, is an
international leader in conducting practice-changing clinical trials
involving advanced radiotherapy techniques and their combination with
new classes of anti-cancer biomarker driven therapies. RTOG Foundation
is the successor to the Radiation Therapy Oncology Group, a 40-year
participant in the cooperative group program funded by the National
Cancer Institute (NCI). RTOG’s mission then and now is to improve the
survival and quality of life of cancer patients. RTOG trials employ
translational research strategies to identify patient subgroups that are
at risk for failure with existing treatments and identify new treatment
options for these patients. RTOG designs and conducts NCI-funded trials
as a founding member of NRG Oncology and collaborates with industry
partners to identify and test promising new agents through multisite
private sector trials. This trial is funded entirely through corporate
support from Novocure and has not been approved by the NCI.
About Novocure
Novocure is an oncology company developing a profoundly different cancer
treatment utilizing a proprietary therapy called TTFields, the use of
electric fields tuned to specific frequencies to disrupt solid tumor
cancer cell division. Novocure’s commercialized product, Optune, is
approved for the treatment of adult patients with glioblastoma. Novocure
has ongoing or completed clinical trials investigating TTFields in brain
metastases, non-small cell lung cancer, 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 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.
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 visit Optune.com/Safety for
Optune Instructions For Use (IFU) for complete information regarding the
device’s indications, contraindications, warnings, and precautions.
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, 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 February 23, 2017, 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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Source: Novocure