Novocure Announces The Lancet Oncology Publishes Primary Data from Phase 3 LUNAR Clinical Trial in Patients with Metastatic Non-Small Cell Lung Cancer After Platinum-Based Therapies
August 29 2023 - 6:31PM
Business Wire
Novocure (NASDAQ: NVCR) announced today that data from the
randomized phase 3 LUNAR clinical trial evaluating the use of Tumor
Treating Fields (TTFields) therapy together with standard systemic
therapies for the treatment of metastatic non-small cell lung
cancer (NSCLC) following progression on or after platinum-based
therapy have been published in The Lancet Oncology.
As presented at the 2023 American Society of Clinical Oncology
Annual Meeting, the LUNAR trial met its primary endpoint, showing a
statistically significant and clinically meaningful 3-month
improvement in median overall survival (OS) when TTFields therapy
was added to physician’s choice of immune checkpoint inhibitor
(ICI) or docetaxel (HR: 0.74, P=0.035). The data demonstrate the
efficacy and safety of TTFields therapy in this setting, with no
systemic toxicities or new safety signals. In addition,
patient-reported data suggest there was no quality-of-life burden
associated with adding TTFields therapy to standard therapy.
“The results of the LUNAR trial support the use of Tumor
Treating Fields therapy in metastatic NSCLC in the second line and
beyond,” said primary investigator Ticiana Leal, M.D., a researcher
and medical oncologist at Winship Cancer Institute of Emory
University and associate professor and director of the Thoracic
Medical Oncology Program in the Department of Hematology and
Medical Oncology at Emory University School of Medicine in Atlanta.
“This is a promising development for a population of patients with
limited treatment options. The results suggest that Tumor Treating
Fields therapy can safely be used along with standard systemic
therapies to extend survival without reducing quality of life.”
Patients randomized to receive TTFields therapy together with
standard therapies (n=137) demonstrated median OS of 13.2 months
compared to 9.9 months in patients treated with standard therapies
alone (n=139). Patients randomized to receive TTFields therapy and
physician’s choice ICI (n=66) demonstrated a median OS of 18.5
months versus a median OS of 10.8 months in patients treated with
an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to
receive TTFields therapy and docetaxel (n=71) had a positive
survival trend with a median OS of 11.1 months vs 8.7 months in
patients treated with docetaxel alone (n=71). TTFields therapy was
well-tolerated with no added systemic toxicities and few grade 3
(no grade 4 or 5) device-related adverse events.
“We are pleased the LUNAR trial results have been published in
The Lancet Oncology, one of the most influential medical journals
in the field of cancer research,” said William Doyle, Novocure’s
Executive Chairman. “The LUNAR data demonstrate the benefit of
TTFields therapy for patients with metastatic non-small cell lung
cancer. We are eager to make our therapy available to this patient
population with high unmet needs, and we are confident TTFields
therapy has a place in current and future standards of care.”
The LUNAR clinical trial data are expected to serve as the basis
for a Premarket Approval (PMA) submission to the U.S. Food and Drug
Administration in the second half of 2023. Novocure recently
completed the LUNAR submission for CE mark.
Read the full article in the latest issue of The Lancet
Oncology.
About LUNAR
LUNAR was a phase 3 trial testing the safety and effectiveness
of TTFields therapy when used together with ICI or docetaxel
(experimental arm) versus ICI or docetaxel alone (control arm) for
patients with metastatic NSCLC who progressed during or after
platinum-based therapy. It is estimated that approximately 46,000
patients receive second-line treatment for metastatic NSCLC each
year in the U.S. The primary endpoint was superior overall survival
of patients treated with TTFields therapy plus ICI or docetaxel
versus ICI or docetaxel alone. The powered secondary endpoints were
superior overall survival of patients treated with TTFields therapy
plus ICI versus ICI cohort and superior overall survival of
patients treated with TTFields therapy plus docetaxel versus
docetaxel alone. TTFields therapy is intended principally for use
with other concomitant standard therapies, and LUNAR was designed
to generate data that contemplates multiple outcomes, all of which
Novocure believes will be clinically meaningful.
About NSCLC
Lung cancer is the most common cause of cancer-related death
worldwide, and NSCLC accounts for approximately 85% of all lung
cancers. It is estimated that approximately 193,000 patients are
diagnosed with NSCLC each year in the U.S. Physicians use different
combinations of surgery, radiation and pharmacological therapies to
treat NSCLC, depending on the stage of the disease. Surgery, which
may be curative in a subset of patients, is usually used in early
stages of the disease. Since 1991, radiation with a combination of
platinum-based chemotherapy drugs has been the first-line standard
of care for locally advanced or metastatic NSCLC. Certain immune
checkpoint inhibitors have been approved for the first-line
treatment of NSCLC and the standard of care in this setting appears
to be evolving rapidly. The standard of care for second-line
treatment is also evolving and may include platinum-based
chemotherapy for patients who received immune checkpoint inhibitors
as their first-line regimen, docetaxel, immune checkpoint
inhibitors or pemetrexed.
About Novocure
Novocure is a global oncology company working to extend survival
in some of the most aggressive forms of cancer through the
development and commercialization of its innovative therapy, Tumor
Treating Fields. Novocure’s commercialized products are approved in
certain countries for the treatment of adult patients with
glioblastoma, malignant pleural mesothelioma and pleural
mesothelioma. Novocure has ongoing or completed clinical trials
investigating Tumor Treating Fields in brain metastases, gastric
cancer, glioblastoma, liver cancer, non-small cell lung cancer,
pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland and with a growing global
footprint, Novocure has regional operating centers in Portsmouth,
New Hampshire and Tokyo, as well as a research center in Haifa,
Israel. For additional information about the company, please visit
Novocure.com and follow @Novocure on LinkedIn and Twitter.
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 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, environmental, regulatory and
political conditions as well as issues arising from the COVID-19
pandemic and other more specific risks and uncertainties facing
Novocure such as those set forth in its Annual Report on Form 10-K
filed on February 23, 2023, and subsequent filings 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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