Mesothelioma patients who received Tumor Treating Fields with
pemetrexed and cisplatin or carboplatin experienced median overall
survival of 18.2 months compared to 12.1 months in historical
control with no increase in systemic toxicity
Results support the use of Tumor Treating Fields in first
potential indication outside of the brain
Company to host analyst and investor briefing Sept. 25, 2018
Novocure (NASDAQ: NVCR) announced final results from its STELLAR
phase 2 registration trial in mesothelioma, demonstrating a
significant extension in median overall survival among patients
treated with Tumor Treating Fields plus standard of care
chemotherapy compared to historical control data of patients who
received standard of care chemotherapy alone. Malignant pleural
mesothelioma patients who received Tumor Treating Fields with
pemetrexed and cisplatin or carboplatin experienced median overall
survival of 18.2 months (95 percent CI, 12.1-25.8 months) compared
to 12.1 months in a historical control. Tumor Treating Fields is a
cancer therapy that uses electric fields tuned to specific
frequencies to disrupt cell division, inhibiting tumor growth and
causing affected cancer cells to die. The final STELLAR results
will be presented at the IASLC 19th World Conference on Lung Cancer
hosted by the International Association for the Study of Lung
Cancer (IASLC) on Sept. 25, 2018, in Toronto.
“The final results of the STELLAR trial demonstrate an
impressive extension of median overall survival in the treatment of
malignant pleural mesothelioma with no increase in systemic
toxicity,” said Giovanni Luca Ceresoli, MD, Head of Pulmonary
Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy, and
an investigator in the STELLAR trial. “Mesothelioma patients face
an urgent unmet need for additional therapies that improve
survival. Based on these data, I believe Tumor Treating Fields
represent an extremely promising therapeutic option that, if
approved, should be added to standard of care chemotherapy for the
treatment of malignant pleural mesothelioma.”
Secondary endpoints also were improved compared to the
historical control. Patients who received Tumor Treating Fields in
combination with pemetrexed and cisplatin or carboplatin
experienced a median progression free survival of 7.6 months (95
percent CI, 6.7-9.8 months) compared to 5.7 months in the
historical control. Partial responses were seen in 40.3 percent of
patients, and clinical benefit, either partial response or stable
disease, was seen in 97.2 percent of patients. No serious
device-related adverse events were reported. Skin irritation was
reported in 46 percent of patients using Tumor Treating Fields,
with only 4 patients (5 percent) reporting grade 3 skin
irritation.
The single-arm, open-label, multi-center trial was designed to
test the efficacy and safety of Tumor Treating Fields in
combination with standard of care chemotherapy, pemetrexed combined
with cisplatin or carboplatin, in 80 patients with unresectable,
previously untreated malignant pleural mesothelioma. The primary
endpoint was overall survival and secondary endpoints were response
rate, progression free survival and adverse events. Median age of
patients was 67, 84 percent were male, 56 percent were smokers, 16
percent had metastatic disease, 44 percent had an ECOG PS of 1, and
66 percent had epithelioid histology. The historical control for
this trial was the 2003 pemetrexed phase 3 registration trial,
which had a similar percentage of patients with epithelioid
histology.
Novocure received a Humanitarian Use Device (HUD) designation
for the use of Tumor Treating Fields for the treatment of malignant
pleural mesothelioma in 2017 and plans to submit a Humanitarian
Device Exemption (HDE) application to the U.S. Food and Drug
Administration (FDA) for approval later this year.
“We are extremely pleased by the results of the STELLAR trial,”
said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of
Research and Development. “We believe the results support the use
of Tumor Treating Fields in our first indication outside of the
brain. We are now one step closer to commercializing Tumor Treating
Fields as a treatment for malignant pleural mesothelioma.”
Novocure will host an analyst and investor briefing Tuesday,
Sept. 25, 2018 from 12:30 p.m. to 2 p.m. EDT in Toronto to review
data presented at IASLC and to provide a general update on research
and development activities. The event will be webcast live and can
be accessed from the Investor Relations page of Novocure’s website,
www.novocure.com/investor-relations. The webcast will be available
for replay for at least 14 days following the event.
Tumor Treating Fields in combination with standard of care
chemotherapy is an investigational treatment for malignant pleural
mesothelioma and is not approved for this indication.
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is a rare thoracic solid tumor
cancer that has been strongly linked to asbestos exposure. It has a
long latency period of at least 20-30 years following exposure, and
global incidence is still increasing in countries where asbestos is
still in use. There are approximately 3,000 new cases of
mesothelioma annually in the United States. The prognosis of
mesothelioma patients is very poor, with a median overall survival
of approximately 12 months in most reported studies.
About Novocure
Novocure is an oncology company developing a profoundly
different cancer treatment utilizing a proprietary therapy called
Tumor Treating Fields, the use of electric fields tuned to specific
frequencies to disrupt solid tumor cancer cell division. Novocure’s
commercialized product is approved for the treatment of adult
patients with glioblastoma. Novocure has ongoing or completed
clinical trials investigating Tumor Treating Fields 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,
Japan and Israel. For additional information about the company,
please visit www.novocure.com or follow us at
www.twitter.com/novocure.
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 22, 2018, 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/20180905005706/en/
Media and Investor Contact:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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