Market Overview

Combination of Optune™ with Standard of Care Chemotherapy, Temozolomide, Provides Landmark Five-Year Survival Rates for Newly Diagnosed Glioblastoma Patients

Share:





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.

View Comments and Join the Discussion!