Data show glioblastoma patients who received Optune in
combination with bevacizumab at first recurrence lived longer than
patients who received bevacizumab alone
Novocure (NASDAQ:NVCR) announced today that data from a post hoc
analysis of the EF-14 pivotal phase 3 clinical trial of Optune in
combination with temozolomide for the treatment of newly diagnosed
glioblastoma (GBM) have been published in CNS Oncology. The
objective of the pre-specified post hoc analysis was to evaluate
the efficacy and safety of Optune when added to physician’s best
choice second-line treatment after first disease recurrence among
patients enrolled in the EF-14 trial.
The analysis shows that the median overall survival of patients
treated with Optune in combination with physician’s best choice
second line chemotherapy increased by 28 percent compared to
patients treated with physician’s best choice second line
chemotherapy alone from 9.2 months to 11.8 months (HR= 0.70, p=
0.049). Bevacizumab, alone or in combination with chemotherapy, was
the most frequently used second-line treatment. The analysis also
shows that the median overall survival of patients treated with
Optune in combination with bevacizumab increased by 31 percent
compared to patients treated with bevacizumab alone from 9.0 months
to 11.8 months (HR=0.61, p= 0.043).
“Taken in conjunction with the previously reported benefits with
TTFields for newly diagnosed GBM in the EF-14 interim analysis,
these results support the early initiation and continued use of
Optune in combination with standard systemic therapies for the
treatment of GBM,” said Santosh Kesari, a trial investigator and
Chair of Translational Neurosciences and Neurotherapeutics at John
Wayne Cancer Institute and Director of Neuro-oncology at the
Pacific Neuroscience Institute at Providence Saint John’s Health
Center in Santa Monica, California. “The publication of these data
adds to the growing body of evidence around Optune’s efficacy and
supports the incorporation of Optune as a combination treatment for
patients with glioblastoma.”
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/20170417005302/en/
Media and Investors:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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