First Patient Enrolled in Novocure’s Phase 3 Pivotal LUNAR Trial Testing Tumor Treating Fields for the Treatment of Advance...
15 February 2017 - 11:00PM
Business Wire
The trial will test the efficacy and safety of
TTFields at 150 kHz in combination with two of the current standard
of care treatments, immune checkpoint inhibitors or docetaxel
Novocure (NASDAQ: NVCR) announced today that the first patient
has been enrolled in LUNAR, its phase 3 pivotal trial of Tumor
Treating Fields at 150 kHz as a treatment for advanced non-small
cell lung cancer (NSCLC) after failing platinum-based therapy. The
prospective, randomized, controlled trial will test the efficacy
and safety of TTFields in combination with immune checkpoint
inhibitors or docetaxel – a taxane chemotherapy – two of the
current standard of care treatments.
The international trial is planned to include 512 patients with
stage IIIB and IV NSCLC of all histologies after failing
platinum-based therapy. The primary endpoint is superior overall
survival of patients treated with TTFields plus immune checkpoint
inhibitors or docetaxel versus immune checkpoint inhibitors or
docetaxel alone. In addition, the trial will test non-inferiority
in overall survival of patients treated with TTFields plus
docetaxel versus immune checkpoint inhibitors alone.
“We designed this trial to test TTFields with two of the
currently available standard of care treatments for advanced NSCLC
following failure of platinum-based therapy, opening the trial to
more patients with this disease,” said Dr. Eilon Kirson, Novocure’s
Chief Science Officer and Head of Research and Development. “We are
excited about the potential of TTFields for the treatment of
advanced NSCLC, and we are pleased to start this pivotal
trial.”
The LUNAR trial design was based on preclinical findings that
suggest TTFields may act synergistically with certain taxanes and
enhance the efficacy of immune checkpoint inhibitors. In addition,
the trial design was informed by Novocure’s phase 2 pilot EF-15
trial1, which tested TTFields at 150 kHz in combination with
pemetrexed chemotherapy in 42 patients with advanced second- or
subsequent-line NSCLC. The EF-15 study showed that TTFields are
safe and tolerable in patients with advanced NSCLC. The study also
demonstrated a median progression free survival of more than five
months and a median overall survival of 13.8 months. These results
exceeded historical results for second-line treatment of advanced
NSCLC with pemetrexed chemotherapy alone. Notably, the EF-15 trial
also included patients with squamous histology (n=7, 17 percent),
who typically do not respond to treatment with pemetrexed.
“The start of LUNAR, our second ongoing phase 3 trial beyond
glioblastoma, further demonstrates our commitment to testing
TTFields across a variety of solid tumor cancers and bringing our
therapy to patients who may benefit from it,” said Novocure CEO
Asaf Danziger. “We believe that treatment with TTFields is bigger
than one cancer type. We are developing a profoundly different
approach to cancer therapy that has the potential to improve the
lives of people affected by a range of solid tumor cancers.”
For more information on the trial design, visit
ClinicalTrials.gov.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related death in the
United States. Non-small cell lung cancer (NSCLC) accounts for
approximately 85 percent of all lung cancers. The incidence of
NSCLC in the U.S. is approximately 185,000 new cases annually.
Tumor Treating Fields (TTFields) therapy is not approved for the
treatment of NSCLC by the U.S. Food and Drug Administration. The
safety and effectiveness of TTFields therapy for NSCLC has not been
established.
About Novocure
Novocure is a commercial-stage oncology company developing a
proprietary therapy called Tumor Treating Fields, or TTFields, for
the treatment of solid tumor cancers. Novocure’s commercialized
product, Optune, is approved for the treatment of adult patients
with glioblastoma. Novocure has ongoing phase 3 pivotal trials in
brain metastases from NSCLC and in advanced NSCLC after failing
platinum-based therapy. Novocure has ongoing or completed phase 2
pilot trials investigating TTFields in 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.
Forward-Looking Statements
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condition, this press release may contain forward-looking
statements. Forward-looking statements provide Novocure’s current
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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 March 1, 2016, 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.
1 Pless M. et al., A phase I/II trial of Tumor Treating Fields
(TTFields) therapy in combination with pemetrexed for advanced
non-small cell lung cancer. Lung Cancer. 2013 Jul 23. pii:
S0169-5002(13)00308-5. doi: 10.1016
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Media and Investor ContactNovocureAshley Cordova,
212-767-7558acordova@novocure.com
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