The METIS trial demonstrated 21.9 months median time to
intracranial progression for patients treated with TTFields therapy
and supportive care compared to 11.3 months for patients treated
with supportive care alone
Patients treated with TTFields therapy experienced prolonged
quality of life deterioration-free survival and TTFields therapy
was well-tolerated
Data from the METIS trial to be presented today during the 2024
ASCO Annual Meeting
Novocure (NASDAQ: NVCR) today announced the presentation of
clinical data from the phase 3 METIS trial, which investigated the
use of Tumor Treating Fields (TTFields) therapy in the treatment of
brain metastases from non-small cell lung cancer (NSCLC). These
data will be presented at the ongoing 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago.
The METIS trial enrolled 298 adult patients with 1-10 brain
metastases from NSCLC, who were randomized following stereotactic
radiosurgery (SRS) to receive either TTFields therapy and best
supportive care (BSC) (n=149) or BSC alone (n=149). METIS met its
primary endpoint, demonstrating a statistically significant
improvement in time to intracranial progression. Patients treated
with TTFields therapy and BSC exhibited a median time to
intracranial progression of 21.9 months compared to 11.3 months in
patients treated with BSC alone (hazard ratio=0.67; P=0.016).
Median TTFields therapy duration was 16 weeks and median usage was
67%. Baseline patient demographics and characteristics were well
balanced between arms.
Patients treated with TTFields therapy demonstrated improved
quality of life deterioration-free survival, with median time to
quality of life deterioration-free survival not reached in the
TTFields therapy cohort compared to 7.7 months in control arm
(P=0.038). A positive trend was observed in patients treated with
TTFields therapy in the majority of scales and items assessed by
the EORTC QLQ C30 and BN20 patient questionnaire. There was no
evidence of worsening cognitive functioning in the TTFields therapy
arm compared to the control arm. Consistent with prior clinical
trials, TTFields therapy was well-tolerated with no additive
systemic toxicity.
Preliminary analyses of key secondary endpoints did not
demonstrate statistical significance. Median overall survival for
patients randomized to receive TTFields therapy and BSC was 11.3
months compared to 10.6 months in patients treated with BSC alone.
Full analysis of secondary endpoints is ongoing.
“One of the key challenges in combatting the spread of brain
metastases is maintaining patients’ quality of life and cognitive
function,” said lead investigator Minesh Mehta, MD, Chief of
Radiation Oncology and Deputy Director at Miami Cancer Institute,
part of Baptist Health South Florida. “The ability of TTFields
therapy to prolong the time to intracranial progression without
negatively impacting either quality of life or cognitive function
has the potential to change the way brain metastases from non-small
cell lung cancer are treated.”
“Despite the high incidence level of brain metastases from
NSCLC, the treatment options available for patients are very
limited,” said Nicolas Leupin, MD, Novocure’s Chief Medical
Officer. “The observations from the METIS trial are an important
first step in potentially adding a new treatment option for these
patients and we are eager to pursue the necessary steps to ensure
TTFields therapy is available to those in need.”
These data will be featured by Dr. Mehta in an oral presentation
(abstract #2008) at 10:24 a.m. CDT on Monday, June 3, 2024 during
ASCO’s Central Nervous System Tumors session. Novocure intends to
publish these findings in a peer-reviewed scientific journal and
submit these data to regulatory authorities.
About METIS
METIS [NCT02831959] is a phase 3 trial of stereotactic
radiosurgery with or without TTFields therapy for patients with
1-10 brain metastases from NSCLC. 298 adult patients were enrolled
in the trial and randomized to receive either TTFields therapy with
supportive care or supportive care alone following SRS. Supportive
care consisted of, but was not limited to, treatment with steroids,
anti-epileptic drugs, anticoagulants, pain control or nausea
control medications. Patients in both arms of the study were
eligible to receive systemic therapy for their NSCLC at the
discretion of their treating physician. Patients with known tumor
mutations for which targeted agents are available were excluded
from the trial.
The primary endpoint of the METIS trial is time to first
intracranial progression, as measured from the date of first SRS
treatment to intracranial progression or neurological death (per
RANO-BM criteria), whichever occurs first. Time to intracranial
progression was calculated according to the cumulative incident
function. Patient scans were evaluated by a blinded, independent
radiologic review committee. Secondary endpoints include, but are
not limited to, time to distant progression, time to neurocognitive
failure, overall survival, time to second intracranial progression,
quality of life and adverse events. Key secondary endpoints (time
to neurocognitive failure, overall survival, and radiological
response rate) were planned to be used in labeling claims, if
successful. Full analysis of secondary endpoints is ongoing.
Patients were stratified by the number of brain metastases (1-4 or
5-10 metastases), prior systemic therapy, and tumor histology.
Patients were allowed to crossover to the experimental TTFields
therapy arm following confirmation of second intracranial
progression.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) are electric fields that exert
physical forces to kill cancer cells via a variety of mechanisms.
TTFields do not significantly affect healthy cells because they
have different properties (including division rate, morphology, and
electrical properties) than cancer cells. The multiple, distinct
mechanisms of TTFields therapy work together to selectively target
and kill cancer cells. Due to its multimechanistic actions,
TTFields therapy can be added to cancer treatment modalities in
approved indications and demonstrates enhanced effects across solid
tumor types when used with chemotherapy, radiotherapy, immune
checkpoint inhibition, or targeted therapies in preclinical models.
TTFields therapy provides clinical versatility that has the
potential to help address treatment challenges across a range of
solid tumors. To learn more about Tumor Treating Fields therapy and
its multifaceted effect on cancer cells, visit
tumortreatingfields.com.
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 and malignant pleural mesothelioma. Novocure has
ongoing or completed clinical studies 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
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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 study 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 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 22, 2024, 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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version on businesswire.com: https://www.businesswire.com/news/home/20240603817216/en/
INVESTORS AND MEDIA: Ingrid Goldberg
investorinfo@novocure.com media@novocure.com
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