Optune is the first FDA-approved therapy in more than a decade to
demonstrate statistically significant extension of survival in newly
diagnosed glioblastoma patients
The EF-14 trial achieved statistically significant extension of both
progression-free survival and overall survival in newly diagnosed
glioblastoma with a 50% increase in the number of patients alive
two-years after starting treatment when treated with TTFields in
combination with temozolomide as compared to temozolomide alone
Company Website:
http://www.novocure.com
ST. HELIER, Jersey -- (Business Wire)
Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug
Administration (FDA) has approved Optune in combination with
temozolomide for the treatment of adult patients with newly diagnosed
glioblastoma (GBM). Optune is a portable, non-invasive device that
delivers low-intensity, intermediate frequency, alternating electric
fields – referred to as Tumor Treating Fields (TTFields) – that inhibit
cancer cell replication and cause cancer cell death.
Optune is the first FDA-approved therapy in more than a decade to
demonstrate statistically significant extension of overall survival in
newly diagnosed GBM. The two-year survival rate among patients treated
with Optune in combination with temozolomide was 50% higher than in
patients treated with temozolomide alone. No significant additive
systemic toxicity was observed in the trial, and patients maintained
stable quality-of-life, cognitive function and activities of daily
living while using Optune.
“Novocure is committed to helping patients with glioblastoma, and we are
proud that Optune has been shown to offer patients such a significant
improvement in both progression-free and overall survival,” said Asaf
Danziger, Novocure’s Chief Executive Officer. “Glioblastoma is the most
common form of primary brain cancer which, until now, has not seen any
significant therapeutic improvements in over a decade. We’re thankful to
the many patients, their caregivers and healthcare providers who
partnered with us to develop a treatment that has finally led to a
significant improvement in the outcomes for patients with glioblastoma.”
The FDA approval follows a priority review of the Optune Premarket
Approval (PMA) supplement application. The FDA grants priority review
status to medical devices that are intended to treat life-threatening
diseases and that offer clinically meaningful advantages over existing
approved alternatives. Optune was previously approved in April 2011 for
the treatment of adult patients with GBM following tumor recurrence
after receiving chemotherapy.
GBM is the most common and aggressive form of primary brain cancer. An
estimated 12,500 people are diagnosed with GBM or tumors that typically
progress to GBM in the United States each year. Median overall survival
in newly diagnosed patients is approximately 15 months with existing
standard therapies.
Proven Superiority vs. Standard of Care in a Phase 3 Clinical Trial
The expanded indication for Optune is based on the results of EF-14, a
large, multinational, open-label, randomized Phase 3 trial comparing
Optune in combination with temozolomide to temozolomide alone in 700
patients with newly diagnosed GBM. The trial was powered to test both
progression-free survival and overall survival.
In November 2014, the trial was stopped due to success based on an
assessment by the independent data monitoring committee which concluded
that the study met its endpoints at its pre-specified interim analysis,
demonstrating superior progression-free and overall survivals in
patients receiving Optune in combination with temozolomide compared to
temozolomide alone.
The EF-14 interim analysis of the pre-specified trial endpoints
demonstrated that:
-
the two-year survival rate among patients treated with TTFields, in
combination with temozolomide, in the as-treated population, was 48%
compared to 32% among patients treated with temozolomide alone
(p=0.0058);
-
patients treated with TTFields, in combination with temozolomide, in
the intent-to-treat population, demonstrated a statistically
significant increase in progression-free survival compared to
temozolomide alone (median progression-free survival of 7.2 months
compared to 4.0 months, hazard ratio=0.62, p=0.001); and
-
patients treated with TTFields, in combination with temozolomide, in
the as-treated population, demonstrated a statistically significant
increase in overall survival compared to temozolomide alone (median
overall survival of 20.5 months compared to 15.6 months, hazard
ratio=0.66, p=0.004).
In addition, the study demonstrated Optune could be safely combined with
temozolomide. There was no significant increase in serious adverse
events from Optune in combination with temozolomide versus temozolomide
alone. The most common adverse reaction from Optune treatment was mild
to moderate skin irritation, which was easily managed, reversible, and
did not result in treatment discontinuation.
“Today marks a significant milestone in glioblastoma treatment,” said
Elizabeth Wilson, President and CEO of the American Brain Tumor
Association, Chicago. “For a disease for which there are few treatment
options, Optune offers new hope for extending survival from the start of
treatment.”
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable,
non-invasive medical device designed for continuous use by patients. In
vitro and in vivo studies have shown that TTFields therapy
slows and reverses tumor growth by inhibiting mitosis, the process by
which cells divide and replicate. TTFields therapy creates low
intensity, alternating electric fields within a tumor that exert
physical forces on electrically charged cellular components, preventing
the normal mitotic process and causing cancer cell death.
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 supra-tentorial 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 (the NovoTTF-100A System) is approved for the treatment
of adult patients with recurrent supra-tentorial glioblastoma after all
possible surgical and radiation therapy 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 in the US or by email at supportEMEA@novocure.com
in the European Union.
About Novocure
Novocure is a Jersey Isle oncology company pioneering a novel therapy
for solid tumors called TTFields. Novocure’s US operations are based in
Portsmouth, NH and New York, NY. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151005006764/en/
Contacts:
Media and Investor Contact:
Novocure
Ashley Cordova,
212-767-7558
acordova@novocure.com
Source: Novocure
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