Final analyses provide unprecedented five-year survival
advantage reinforcing Optune plus temozolomide as a combination
treatment for glioblastoma patients
Survival benefit was maintained in all patient subgroups,
including those with the worst prognostic features
Novocure (NASDAQ:NVCR) announced today final results from its
phase 3 pivotal EF-14 trial adding Optune to standard temozolomide
chemotherapy for the treatment of newly diagnosed glioblastoma
(GBM). Landmark analyses show a consistent and maintained
improvement in overall survival at two, three, four and five years.
The final results include data from all 695 patients included in
the EF-14 trial with a median follow-up of 40 months.
The two-year survival rate increased from 30 percent to 43
percent for patients treated with Optune together with temozolomide
versus patients treated with temozolomide alone. The five-year
survival rate increased from five percent to 13 percent for
patients treated with Optune together with temozolomide versus
patients treated with temozolomide alone. These are the best
results reported for newly diagnosed GBM patients in a phase 3
trial to date and represent clinically meaningful increases in
landmark survival rates (hazard ratio, 0.63; p<0. 00006).
EF-14 Principal Investigator Roger Stupp, M.D., Associate
Director for Strategic Initiatives at the Robert H. Lurie
Comprehensive Cancer Center of Northwestern University, presented
these late breaking results today, April 2, during a press briefing
and oral presentation (Abstract CT007) at the American Association
for Cancer Research Annual Meeting 2017 in Washington D.C.
“When I started treating patients with GBM 20 years ago, the
majority of patients died within less than one year and long-term
survival was nearly absent. Now, we see a meaningful improvement in
survival at two years and beyond,” Dr. Stupp said. “With the
combination of Optune and temozolomide, one out of seven patients
is living longer than five years.”
“This is the first positive phase 3 trial in newly diagnosed GBM
since we demonstrated the efficacy of temozolomide in 2005,
establishing it as a standard first-line therapy,” continued Dr.
Stupp. “Beyond GBM, I believe this trial establishes an entirely
different approach to cancer treatment with minimal toxicity which
may be well suited for combination with conventional treatments for
many other cancer types.”
GBM is the most common form of primary brain cancer. An
estimated 12,500 people are diagnosed with GBM in the United States
each year. Prior to the approval of Optune, the median overall
survival for patients with newly diagnosed GBM was approximately 15
months with standard therapies. Combining Optune with temozolomide
resulted in a statistically significant extension of median overall
survival to 21 months in Novocure’s phase 3 pivotal EF-14
trial.
“We are excited that combination therapy with Optune plus
temozolomide continues to show a meaningful extension of long-term
survival for newly diagnosed GBM patients,” said Elizabeth M.
Wilson, President and CEO of the American Brain Tumor Association.
“Before temozolomide was approved, newly diagnosed GBM patients
only had a 1.9 percent five-year survival rate, so to see numbers
that are over six times that rate shows the significant progress
that has been made in treating this disease.”
The data presented confirmed that the overall survival benefit
of Optune together with temozolomide compared to temozolomide alone
was seen across all patient subgroups including young versus
elderly patients, patients with methylated versus unmethylated MGMT
promoter and patients who underwent any extent of tumor resection.
The data showed a safety profile consistent with previous reports
of data from the study.
“These data further support our belief that Optune plus
temozolomide is an essential combination treatment for patients
with newly diagnosed GBM,” said Asaf Danziger, Novocure’s CEO. “The
efficacy shown in EF-14 for GBM gives us hope that TTFields used in
combination other cancer treatments may increase survival without
significantly increasing side effects for a variety of solid
tumors.”
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
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.
In the European Union, Optune is intended for the treatment of
patients with newly diagnosed GBM, after surgery and radiotherapy
with adjuvant temozolomide, concomitant to maintenance
temozolomide. The treatment is intended for adult patients, 18
years of age or older, and should be started more than 4 weeks
after surgery and radiation therapy with adjuvant temozolomide.
Treatment may be given together with maintenance temozolomide and
after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment
of patients with recurrent GBM who have progressed after surgery,
radiotherapy and temozolomide treatment for their primary disease.
The treatment is intended for adult patients, 18 years of age or
older, and should be started more than 4 weeks after the latest
surgery, radiation therapy or chemotherapy.
In Japan, Optune (NovoTTF-100A) is approved in the treatment of
adult patients with supra-tentorial glioblastoma (GBM) and is used
following maximal safe surgical resection and radiation
therapy.
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 in the US or by email at
supportEMEA@novocure.com in the European Union.
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/20170402005005/en/
Media and Investors:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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