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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190523005776/en/
Media and Investor Contact:Ashley
Cordovaacordova@novocure.com212-767-7558
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