Final data from the TRIDENT trial anticipated in 2026
Novocure (NASDAQ: NVCR) today announced that the final patient
has been enrolled in the global phase 3 TRIDENT clinical trial
evaluating the safety and efficacy of initiating Optune Gio®
(formerly known as Optune®) concurrent with radiation therapy and
temozolomide (TMZ) for the treatment of adult patients with newly
diagnosed glioblastoma (GBM).
“TTFields therapy has played a critical role in the treatment of
newly diagnosed glioblastoma for nearly a decade, and the TRIDENT
trial represents the potential evolution of this treatment paradigm
by introducing TTFields earlier, at the same time as radiation
therapy and temozolomide,” said Asaf Danziger, Novocure’s Chief
Executive Officer. “Preclinical research has shown that the
application of TTFields together with radiation therapy leads to a
more pronounced cytotoxic effect in glioma cell lines as compared
to TTFields after administration of radiation therapy. The TRIDENT
study could unlock our ability to reach patients earlier in their
treatment journey, further extending patient survival. We remain
committed to exploring opportunities to further extend the survival
horizon for patients diagnosed with glioblastoma.”
Optune Gio® is currently approved for use together with
maintenance TMZ for the treatment of newly diagnosed GBM following
maximal debulking surgery and the completion of radiation
therapy.
The TRIDENT clinical trial is a randomized, open-label study
designed to enroll 950 adult patients with newly diagnosed GBM.
Following maximal debulking surgery, patients enrolled in TRIDENT
were randomized to receive either TTFields therapy, concomitant
with TMZ and radiation therapy, or TMZ and radiation therapy for
six weeks. Following the initial six-week period, all patients
receive the current standard of care – TTFields therapy together
with maintenance TMZ for a period of 24 months or until a second
disease progression is experienced. TRIDENT began enrolling
patients in December 2020 and is the largest trial Novocure has
conducted to date.
Final data from the TRIDENT trial is anticipated in 2026. The
trial’s primary endpoint is overall survival. Secondary endpoints
are progression-free survival, one-year and two-year survival rate,
overall radiological response, next progression-free survival,
progression-free survival at six and 12 months, severity and
frequency of adverse events, pathological changes in resected GBM
tumors following study treatments, quality of life, dependence of
overall survival on TTFields dose at the tumor, and neurological
assessment using the NANO scale.
About Optune Gio
Optune Gio delivers Tumor Treating Fields (TTFields) therapy to
the region of the tumor. Optune Gio, previously known as Optune, is
a noninvasive, antimitotic cancer treatment for glioblastoma
(GBM).
TTFields therapy uses electric fields to physically disrupt cell
division. TTFields therapy does not stimulate or heat tissue and
targets dividing cancer cells of a specific size. TTFields therapy
takes advantage of the special characteristics and geometrical
shape of dividing cells, which make them susceptible to the effects
of the alternating electric fields. TTFields therapy causes minimal
damage to healthy cells. Mild to moderate skin irritation is the
most common side effect reported. TTFields therapy is approved in
certain countries for the treatment of adults with glioblastoma,
malignant pleural mesothelioma and pleural mesothelioma, some of
the most difficult cancer types to treat.
Important Safety Information
Contraindications
Do not use Optune Gio in patients with an active implanted
medical device, a skull defect (such as, missing bone with no
replacement), or bullet fragments. Use of Optune Gio together with
implanted electronic devices has not been tested and may
theoretically lead to malfunctioning of the implanted device. Use
of Optune Gio together with skull defects or bullet fragments has
not been tested and may possibly lead to tissue damage or render
Optune Gio ineffective.
Do not use Optune Gio in patients that are known to be sensitive
to conductive hydrogels. In this case, skin contact with the gel
used with Optune Gio may commonly cause increased redness and
itching, and rarely may even lead to severe allergic reactions such
as shock and respiratory failure.
Warnings and Precautions
Do not prescribe Optune Gio for patients that are pregnant, you
think might be pregnant or are trying to get pregnant, as the
safety and effectiveness of Optune Gio in these populations have
not been established.
The most common (≥10%) adverse events involving Optune Gio in
combination with temozolomide were thrombocytopenia, nausea,
constipation, vomiting, fatigue, medical device site reaction,
headache, convulsions, and depression.
The most common (≥10%) adverse events seen with Optune Gio
monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to
Optune Gio when used as monotherapy: medical device site reaction,
headache, malaise, muscle twitching, fall and skin ulcer.
Use of Optune Gio in patients with an inactive implanted medical
device in the brain has not been studied for safety and
effectiveness, and use of Optune Gio in these patients could lead
to tissue damage or lower the chance of Optune Gio being
effective.
If the patient has an underlying serious skin condition on the
scalp, evaluate whether this may prevent or temporarily interfere
with Optune Gio treatment.
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 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 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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Investors & Media: Ingrid Goldberg 610-723-7427
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