Patients treated with Optune® together with
temozolomide demonstrated a significant increase in progression
free and overall survival compared to patients treated with
temozolomide alone
EF-14 patients treated with Optune together
with temozolomide experienced a 70 percent improvement in survival
rate at four years compared to patients treated with temozolomide
alone
Novocure (NASDAQ:NVCR) announced today that a long-term analysis
of the full trial cohort from its phase 3 pivotal EF-14 trial of
Optune® in combination with temozolomide for the treatment of newly
diagnosed glioblastoma (GBM) confirmed the superior survival
results seen at interim analysis. The long-term analysis
demonstrated superior two-, three- and four-year survival of
patients treated with Optune together with temozolomide compared to
temozolomide alone. The interim analysis results – published in the
Journal of the American Medical Association (JAMA) 1 in December
2015 – showed significant extension of both progression free and
overall survival in newly diagnosed GBM patients receiving Optune
with temozolomide compared to temozolomide alone.
EF-14 Principal Investigator Roger Stupp, M.D., Professor at the
University of Zurich and Director of Department of Oncology at the
Zurich University Hospital, Zurich, Switzerland, will present these
late breaking results at the 21st Annual Scientific Meeting of the
Society for Neuro-Oncology (SNO) on Nov. 18, in Scottsdale,
Arizona.
“The analysis of the full dataset confirms the improvement in
both progression free and overall survival we saw in the trial’s
interim analysis, and demonstrates superior long-term survival,”
Dr. Stupp said. “These mature results further validate Optune as a
standard of care treatment option for glioblastoma, providing
patients with a therapy that can extend their survival while
maintaining their quality of life.”
“We are excited that Novocure’s long-term analysis of the EF-14
trial confirms the interim analysis results of superior overall and
progression free survival, while providing new data on potential
long-term survival benefits for newly diagnosed GBM patients,” said
Elizabeth M. Wilson, President and CEO of the American Brain Tumor
Association. “GBM patients need better treatment options, and it is
a great day when new evidence shows that we are making progress in
treating this disease.”
The long-term analysis of all patients (n=695) shows that:
- Patients treated with Optune together
with temozolomide demonstrated a significant increase in median
progression free survival (PFS) compared to temozolomide alone
(median PFS of 6.7 months versus 4.0 months, respectively, hazard
ratio=0.63, p=0.00005).
- Patients treated with Optune together
with temozolomide demonstrated a significant increase in median
overall survival (OS) compared to temozolomide alone (median OS
from randomization of 20.8 months versus 16.0 months, respectively,
hazard ratio=0.65, p=0.0006)
- The percentage of patients alive at two
years in the Optune together with temozolomide arm was 43 percent
compared to 30 percent in the temozolomide alone arm, a 43%
increase in the chance of living two years.
- The percentage of patients alive at
four years in the Optune together with temozolomide arm was 17
percent compared to 10 percent in the temozolomide alone arm, a 70%
increase in the chance of living four years.
- Consistent with the interim analysis,
the OS and PFS benefit of Optune together with temozolomide
compared to temozolomide alone was seen across all patient
subgroups tracked in the EF-14 trial, including patient age,
performance status and tumor genetics.
- The safety profile in the long-term
analysis was consistent with the interim analysis of the EF-14
trial.
“The long-term analysis further supports our data showing that
Optune together with temozolomide is a better treatment option for
newly diagnosed GBM patients compared to temozolomide alone,” said
Asaf Danziger, Novocure’s CEO. “We believe these results will give
health care providers further confidence in our therapy and
transform the standard of care in newly diagnosed GBM. Our priority
is to improve the lives of GBM patients, and we believe these
results will help us to accomplish our mission.”
About Novocure
Novocure 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 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 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.
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 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.
1 Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy
with tumor-treating fields plus temozolomide vs temozolomide alone
for glioblastoma: a randomized clinical trial. JAMA.
2015;314(23):2535-2543.
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version on businesswire.com: http://www.businesswire.com/news/home/20161118005129/en/
Media and InvestorNovocureAshley Cordova,
212-767-7558acordova@novocure.com
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