Data suggest combined modality treatment with TTFields and
triplet combination chemotherapy may extend survival in patients
with recurrent glioblastoma
Novocure (NASDAQ: NVCR) today announced that four abstracts
focusing on Tumor Treating Fields (TTFields) will be presented at
the upcoming 69th American Academy of Neurology (AAN) annual
meeting on April 22-28, in Boston. All four abstracts were
submitted by external researchers, representing a growing interest
in Novocure’s proprietary TTFields therapy.
Among the highlights is a presentation on the overall survival
benefits of TTFields in combination with triplet combination
chemotherapy for recurrent glioblastoma (GBM). Forty-six patients
at The University of Texas Health Center in Houston were identified
who received Optune, Novocure’s TTFields delivery system, at
initial diagnosis or at recurrence from 2010 to 2016. At
recurrence, 21 patients received Optune with a triplet combination
chemotherapy regimen consisting of temozolomide, bevacizumab, and
irinotecan and 25 patients received Optune with bevacizumab alone,
bevacizumab plus irinotecan, or bevacizumab plus temozolomide. The
median overall survival for patients receiving the combination of
Optune plus triplet combination chemotherapy was 32.8 months and
the median overall survival for patients receiving Optune plus the
alternative chemotherapy regimen was 16.5 months, demonstrating a
superior overall survival benefit when Optune was combined with
triplet combination chemotherapy at recurrence. The side effect
profiles for both patient populations was similar.
“We have seen in post-hoc analyses of our EF-14 phase 3 pivotal
clinical trial data that GBM patients continued to benefit from
treatment with Optune even after their disease recurred,” said Dr.
Eilon Kirson, Novocure’s Chief Science Officer and Head of Research
and Development. “Dr. Zhu’s research on the optimal combination
chemotherapy regimen further strengthens our understanding on how
to combine Optune with other cancer treatments to improve patient
outcomes in GBM.”
The scheduled times of the presentations and locations at the
Boston Convention and Exhibition Center are as follows:
Tumor Treating Fields with Triple Chemotherapy for Recurrent
Glioblastoma
- Presenter: Jay-Jiguang Zhu
- Poster Session I: Neuro-oncology
Gliomas I, Publication 177
- Sunday, April 23, 4:00-5:30 p.m.
Eastern Time
Compliance of Tumor Treating Fields Therapy and Overall Survival
in Glioblastoma
- Presenter: Eric Wong
- Poster Session I: Neuro-oncology
Gliomas I, Publication 166
- Sunday, April 23, 4:00-5:30 p.m.
Eastern Time
Analysis of Glioblastoma Physical Characteristics in Patients
Benefiting from Tumor Treating Fields Therapy
- Presenter: Pyay San
- Poster Session I: Neuro-oncology
Gliomas I, Publication 178
- Sunday, April 23, 4:00-5:30 p.m.
Eastern Time
Tumor Treating Fields Distribution in Glioblastoma Volume
Depends on Conductivity Parameters
- Presenter: Edwin Lok
- Poster Session V: Neuro-oncology
Gliomas II, Publication 169
- Thursday, April 27, 5:30-7:00 p.m.
Eastern Time
About Novocure
Novocure is an oncology company developing a profoundly
different cancer treatment centered on 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 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.
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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version on businesswire.com: http://www.businesswire.com/news/home/20170419005144/en/
Media and Investor Contact:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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