Increased compliance with Optune predicted survival in
Novocure’s phase 3 pivotal EF-14 trial in newly diagnosed
glioblastoma
An Optune compliance threshold as low as 50 percent correlated
with significantly improved outcomes in patients treated with
Optune together with temozolomide versus patients treated with
temozolomide alone
Novocure (NASDAQ:NVCR) announced today results from a
retrospective post-hoc analysis of its phase 3 pivotal EF-14 trial
data showing that increased compliance with Optune predicted
increased survival in glioblastoma (GBM) patients. Results were
highlighted in an oral presentation at the 22nd Annual Meeting of
the Society for Neuro-Oncology (SNO) in San Francisco.
The analysis showed that an Optune compliance threshold as low
as 50 percent correlated with significantly improved outcomes in
patients treated with Optune together with temozolomide compared to
patients treated with temozolomide alone. The results also
demonstrated that the greater patients’ compliance with Optune, the
better their outcomes. Patients who used Optune more than 90
percent of the time (n=43) had the greatest chance of survival: a
median survival of 24.9 months from randomization and a five-year
survival of 29.3 percent. The median time from diagnosis to
randomization was 3.8 months for patients treated with Optune
together with temozolomide.
“Increased compliance with Optune led to increased survival in
GBM,” said Zvi Ram, MD, Director of Neurosurgery at the Tel-Aviv
Sourasky Medical Center in Tel-Aviv, who presented the data at SNO.
“These data show that nearly one in three GBM patients in the EF-14
trial who were more than 90 percent compliant with Optune reached
five-year survival. Compliance with Optune matters and changed the
course of the disease for many GBM patients. I feel honored to
share these insightful data.”
Novocure’s phase 3 pivotal EF-14 trial compared Optune in
combination with temozolomide to temozolomide alone in 695 patients
with newly diagnosed GBM. The trial was designed to test both
progression free survival (PFS) and overall survival (OS). The
trial demonstrated unprecedented five-year survival results in
newly diagnosed GBM. Patients treated with Optune in combination
with temozolomide experienced a significant extension of overall
survival without added systemic toxicity compared to patients
treated with temozolomide alone. The data also showed that
Optune-treated patients were able to maintain quality of life for
longer compared to patients treated with temozolomide alone.
Patients in the EF-14 trial treated with Optune together with
temozolomide were recommended to use Optune 75 percent of the time,
or 18 hours per day. This new analysis demonstrated that a
threshold value as low as 50 percent compliance with Optune led to
an extension of both PFS (n= 62, HR 0.70, 95 percent CI 0.47–1.05)
and OS (n= 62, HR 0.67, 95 percent CI 0.45–0.99) versus
temozolomide alone. As compliance increased to 75 percent or
greater, the survival benefit significantly increased (p=0.031).
Patients who used Optune 70-80 percent of the time had a median
survival of 21.7 months (n= 91). Patients who used Optune more than
90 percent of the time had the greatest chance of survival: a
median survival of 24.9 months from randomization and a five-year
survival of 29.3 percent (>90 percent compliance: n= 43, PFS HR
0.54, 95 percent CI 0.37–0.79; OS HR 0.52, 95 percent CI
0.35–0.79). The median time from diagnosis to randomization was 3.8
months for patients treated with Optune together with temozolomide.
The data also show that increased compliance independently
predicted survival and was not affected by prognostic factors such
as performance status, age or MGMT methylation.
“We are pleased with this latest analysis showing that GBM
patients who were the most compliant with Optune had the greatest
chance of five-year survival,” said Novocure CEO Asaf Danziger. “We
are committed to further exploring our EF-14 data with the hopes of
improving treatment outcomes in GBM.”
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, Optune, 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 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, 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/20171117005195/en/
Media and Investors:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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