NovoTTF-100L, a Tumor Treating Fields delivery system, is the first
FDA-approved mesothelioma treatment in more than 15 years
In the STELLAR trial, malignant pleural mesothelioma patients treated
with Tumor Treating Fields plus platinum-based chemotherapy experienced
a median overall survival of 18.2 months
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) today announced that the U.S. Food and Drug
Administration (FDA) has approved the NovoTTF-100L System in combination
with pemetrexed plus platinum-based chemotherapy for the first-line
treatment of unresectable, locally advanced or metastatic, malignant
pleural mesothelioma (MPM). NovoTTF-100L is a non-invasive, antimitotic
cancer treatment that delivers Tumor Treating Fields to the region of
the tumor. Tumor Treating Fields therapy uses electric fields tuned to
specific frequencies to disrupt solid tumor cancer cell division.
NovoTTF-100L is the first treatment for MPM approved by the FDA in more
than 15 years. Preclinical data showed that human mesothelioma cells are
highly sensitive to Tumor Treating Fields. In the STELLAR registration
trial, 80 unresectable MPM patients treated with Tumor Treating Fields
plus chemotherapy experienced a median overall survival of 18.2 months
(95% CI 12.1-25.8).
MPM is a rare cancer that has been strongly linked to asbestos exposure.
Approximately 3,000 people are diagnosed with MPM in the United States
annually. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus
cisplatin was the only FDA-approved therapy for patients with
unresectable MPM.
NovoTTF-100L for MPM is classified as a Humanitarian Use Device (HUD)
and was approved under Humanitarian Device Exemption (HDE). The HDE
pathway was created to encourage companies to innovate in rare diseases
with underserved patient populations. The FDA approved Optune®, another
Tumor Treating Fields delivery system, under the Premarket Authorization
(PMA) pathway in 2011 for the treatment of glioblastoma (GBM). Since
2011, more than 12,000 patients with GBM have been treated with Tumor
Treating Fields.
“Since 2000, we have been developing and commercializing Tumor Treating
Fields to extend survivals in some of the most aggressive forms of
cancer,” said Bill Doyle, Novocure’s Executive Chairman. “FDA approval
of NovoTTF-100L provides patients with the first FDA-approved treatment
for MPM in more than 15 years and, as our first FDA-approved torso
cancer indication, marks a major milestone for Novocure. We are thankful
for the patients, caregivers and health care providers who partnered
with us to make this possible.”
“MPM is a devastating disease, with only 10 to 20 percent of patients
being candidates for surgery to remove the tumor,” said Mary Hesdorffer,
NP, Executive Director of the Mesothelioma Applied Research Foundation.
“Typically, mesothelioma patients who cannot have surgery receive
palliative care to mitigate their symptoms. NovoTTF-100L provides
unresectable MPM patients with a treatment option that may improve
survival. We are encouraged by the FDA approval and hope it is just the
beginning of innovation in the treatment of this aggressive disease.”
Efficacy outcomes in the STELLAR trial
The FDA approval is based on the results of the STELLAR trial. STELLAR
was a prospective, single-arm trial designed to study the safety and
efficacy of NovoTTF-100L plus chemotherapy first-line in patients with
unresectable MPM. The trial included 80 patients with unresectable and
previously untreated MPM who were candidates for treatment with
pemetrexed and cisplatin or carboplatin. The trial was powered to
prospectively determine the overall survival in patients treated with
NovoTTF-100L plus chemotherapy. Secondary endpoints included overall
response rate (per mRECIST criteria), progression free survival and
safety.
The median overall survival was 18.2 months (95% CI 12.1-25.8) across
all patients treated with NovoTTF-100L plus chemotherapy. The median
overall survival was 21.2 months for patients with epithelioid MPM
(n=53) and 12.1 months for patients with non-epithelioid MPM (n=21).
More than half, 62 percent, of patients (n=80) enrolled in the STELLAR
trial who used NovoTTF-100L plus chemotherapy were still alive at one
year. The disease control rate in patients with at least one follow-up
CT scan performed (n=72) was 97 percent. 40 percent of patients had a
partial response, 57 percent had stable disease, and 3 percent had
progressive disease. The median progression free survival was 7.6 months.
In addition, the STELLAR trial demonstrated that NovoTTF-100L could be
combined with chemotherapy. There was no increase in serious systemic
adverse events when NovoTTF-100L was added to chemotherapy.
Mild-to-moderate skin irritation was the most common device-related side
effect with NovoTTF-100L.
Caution: Federal law restricts this device to sale by or on the order of
a physician. Humanitarian Device. Authorized by Federal Law for use in
the treatment of adult patients with unresectable, locally advanced or
metastatic, malignant pleural mesothelioma concurrently with pemetrexed
and platinum based chemotherapy. The effectiveness of this device for
this use has not been demonstrated.
About Novocure
Novocure is a global oncology company working to extend survival in some
of the most aggressive forms of cancer by developing and commercializing
its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is
a cancer therapy that uses electric fields tuned to specific frequencies
to disrupt solid tumor cancer cell division. Novocure’s commercialized
products are approved for the treatment of adult patients with
glioblastoma and malignant pleural mesothelioma. Novocure has ongoing
clinical trials investigating Tumor Treating Fields in brain metastases,
non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver
cancer.
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
The NovoTTF-100L System is indicated for the treatment of adult patients
with unresectable, locally advanced or metastatic, malignant
mesothelioma (MPM) to be used concurrently with pemetrexed and
platinum-based chemotherapy.
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.
Important Safety Information
Contraindications
Do not use the NovoTTF-100L System in patients with MPM with implantable
electronic medical devices such as pacemakers or implantable automatic
defibrillators, etc. Do not use Optune in patients with GBM with an
implanted medical device, a skull defect (such as, missing bone with no
replacement), or bullet fragments. 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.
Use of the NovoTTF-100L System for MPM or Optune for GBM together with
implanted electronic devices has not been tested and may lead to
malfunctioning of the implanted device.
Do not use the NovoTTF-100L System for MPM or Optune for GBM in patients
known to be sensitive to conductive hydrogels. Skin contact with the gel
used with the NovoTTF-100L System and Optune may commonly cause
increased redness and itching, and may rarely lead to severe allergic
reactions such as shock and respiratory failure.
Warnings and Precautions
The NovoTTF-100L System and Optune can only be prescribed by a
healthcare provider that has completed the required certification
training provided by Novocure®.
The most common (≥10%) adverse events involving the NovoTTF-100L System
in combination with chemotherapy in patients with MPM were anemia,
constipation, nausea, asthenia, chest pain, fatigue, device skin
reaction, pruritus, and cough.
Other potential adverse effects associated with the use of the
NovoTTF-100L System include: treatment related skin toxicity, allergic
reaction to the plaster or to the gel, electrode overheating leading to
pain and/or local skin burns, infections at sites of electrode contact
with the skin, local warmth and tingling sensation beneath the
electrodes, muscle twitching, medical site reaction and skin
breakdown/skin ulcer.
The most common (≥10%) adverse events involving Optune in combination
with chemotherapy in patients with GBM were thrombocytopenia, nausea,
constipation, vomiting, fatigue, convulsions, and depression.
The most common (≥10%) adverse events related to Optune treatment alone
in patients with GBM were medical device site reaction and headache.
Other less common adverse reactions were malaise, muscle twitching, and
falls related to carrying the device.
If the patient has an underlying serious skin condition on the treated
area, evaluate whether this may prevent or temporarily interfere with
the NovoTTF-100L System and Optune treatment.
Do not prescribe the NovoTTF-100L System or Optune for patients that are
pregnant, you think might be pregnant or are trying to get pregnant, as
the safety and effectiveness of NovoTTF-100L System and Optune in these
populations have not been established.
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, clinical trial progress,
development of potential products, interpretation of clinical results,
prospects for regulatory submission and approval, manufacturing
development and capabilities, market prospects for its products,
coverage, collections from third-party payers 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 28, 2019, 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.
Contacts
Media and Investor Contact:
Ashley Cordova
acordova@novocure.com
212-767-7558