The first treatment of its kind for metastatic
NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1
inhibitors or docetaxel in adult patients with metastatic NSCLC who
progressed on or after a platinum-based regimen
Results of the pivotal Phase 3 LUNAR trial
represent the first substantial improvement in median overall
survival in more than 8 years for this patient population
Optune Lua is a wearable treatment that
delivers Tumor Treating Fields (TTFields), which exert physical
forces on the electrically charged components of dividing cancer
cells, resulting in cell death
Novocure (NASDAQ: NVCR) announced today that the U.S. Food and
Drug Administration (FDA) has approved Optune Lua® for concurrent
use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of
adult patients with metastatic non-small cell lung cancer (mNSCLC)
who have progressed on or after a platinum-based regimen.
“Novocure is committed to extending survival in some of the most
aggressive and difficult to treat cancers. The approval of Optune
Lua brings a new and urgently needed option for people with
metastatic NSCLC who have progressed while on or after
platinum-based chemotherapy,” said Asaf Danziger, CEO, Novocure.
“We are grateful to the patients, caregivers, investigators and
healthcare providers who supported the clinical trials that led to
this approval.”
Optune Lua is a portable device that produces alternating
electric fields known as tumor treating fields (TTFields), which
are delivered through non-invasive, wearable arrays. TTFields exert
physical forces on the electrically charged components of dividing
cancer cells, resulting in cell death.
“There have been a number of important advances in first-line
treatment for NSCLC, but this is an aggressive disease, and most
patients will develop progression, with limited effective treatment
options in second line and beyond,” said Ticiana Leal, MD,
Associate Professor and Director of the Thoracic Oncology Program
at the Winship Cancer Institute of Emory University School of
Medicine and primary investigator of the LUNAR study. “The overall
survival results we observed with Optune Lua in the LUNAR study
mark the first substantial improvement in more than 8 years in this
patient population which, when combined with Optune Lua’s lack of
systemic toxicity, make this a compelling development for many
patients and their physicians who need better treatment options for
this advanced disease.”
"We are excited patients with metastatic NSCLC have more
options, which they urgently need,” said GO2 for Lung Cancer Chief
Patient Officer Danielle Hicks. “The fight against lung cancer is
always evolving, and the number of people affected by this disease
is underappreciated. That is why Novocure’s commitment to advancing
treatment is exciting for the whole lung cancer community.”
Data Supporting the Optune Lua Approval
The Phase 3 LUNAR study was a prospective, randomized,
open-label, multicenter study that compared the use of Optune Lua
concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental
arm) to PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for
patients with metastatic NSCLC who progressed during or after
platinum-based therapy.
The primary endpoint of the study was achieved demonstrating a
statistically significant and clinically meaningful 3.3-month
(P=0.04) extension in median overall survival (OS) for patients
treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or
docetaxel (n=145). The group treated with Optune Lua concurrently
with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2
months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9
months (95% CI, 8.2 to 12.2 months) in the PD-1/PD-L1 inhibitor or
docetaxel treated group (n=146).
The LUNAR study included two pre-specified powered secondary
endpoints. The first secondary endpoint, which met statistical
significance, assessed median OS in patients treated with Optune
Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1
inhibitor alone. The second secondary endpoint, which showed a
positive trend but did not meet statistical significance, assessed
Optune Lua concurrently with docetaxel versus docetaxel alone.
Patients randomized to Optune Lua and a PD-1/PD-L1 inhibitor
(n=70) demonstrated a median OS of 19.0 months (95% CI, 10.6 to
28.2 months) compared to a median OS of 10.8 months (95% CI, 8.3 to
17.6 months) in patients treated a with PD-1/PD-L1 inhibitor alone
(n=71), which was a statistically significant extension in median
OS of more than 8.0 months (P=0.02).
Patients randomized to receive Optune Lua and docetaxel (n=75)
had a median OS of 11.1 months (95% CI, 8.2 to 13.9 months)
compared to a median OS of 8.9 months (95% CI, 6.5 to 11.3 months)
in patients treated with docetaxel alone (n=75). This 2.2 month
extension in median OS did not provide a statistically significant
demonstrated benefit, but did show a positive trend.
Device-related adverse events (AEs) occurred in 63.1% of
patients (n=89), these were skin-related disorders under the
transducer arrays. The majority of these events were low grade
(Grade 1 - 2), with only 4% (n=6) experiencing Grade 3 skin
toxicity that required a break from treatment. There were no Grade
4 or Grade 5 toxicities related to Optune Lua, and no
device-related AEs that caused death.
Baseline patient characteristics were well balanced between
cohorts: median age was 65 years (range, 22-86); 66% male, 34%
female; 96% of patients had an ECOG performance status of 0-1.
PD-L1 expression data were collected from 83% of patients (69 of 83
patients) enrolled at U.S. sites and were well balanced across the
four cohorts.
Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the most common cause of cancer-related death
worldwide1, and non-small cell lung cancer (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,
including both PD-1 and PD-L1 inhibitors, have been approved for
the first-line treatment of NSCLC and the standard of care in this
setting continues to evolve rapidly.
It is estimated that approximately 30,000 patients actively seek
treatment for stage 4 NSCLC after progressing during or after
platinum-based therapy each year in the U.S. 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, pemetrexed,
docetaxel or immune checkpoint inhibitors.
What is Optune Lua® approved to treat?
Optune Lua is a wearable, portable, FDA-approved device used
together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel.
It is indicated for adult patients with metastatic non-small cell
lung cancer (mNSCLC) who have progressed on or after a
platinum-based regimen.
Important Safety Information
Who should not use Optune Lua?
Optune Lua for mNSCLC is not for everyone. Talk to your doctor
if you have:
- An electrical implant. Use of Optune Lua together with
electrical implants has not been tested and may cause the implanted
device not to work properly
- A known sensitivity to gels like the gel used on
electrocardiogram (ECG) stickers or transcutaneous electrical nerve
stimulation (TENS) electrodes. In this case, skin contact with the
gel used with Optune Lua may commonly cause increased redness and
itching, and rarely may even lead to severe allergies such as a
fall in blood pressure and difficulty breathing
Do not use Optune Lua if you are pregnant or are planning to
become pregnant. It is not known if Optune Lua is safe or
effective during pregnancy.
What should I know before using Optune Lua?
Optune Lua should only be used after receiving training from
qualified personnel, such as your doctor, a nurse, or other medical
staff who have completed a training course given by Novocure®, the
maker of Optune Lua.
- Do not use any parts that did not come with Optune Lua
Treatment Kit sent to you by Novocure or given to you by your
doctor
- Do not get the device or transducer arrays wet
- Please be aware that Optune Lua has a cord that plugs into an
electrical socket. Be careful of tripping when it's connected
- If you have an underlying serious skin condition where the
transducer arrays are placed, discuss with your doctor whether this
may prevent or temporarily interfere with Optune Lua treatment
What are the possible side effects of Optune Lua?
The most common side effects of Optune Lua when used together
with certain immunotherapy and chemotherapy drugs were dermatitis,
pain in the muscles, bones, or joints, fatigue, anemia, alopecia
(hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus
(itching), leukopenia, pneumonia, respiratory tract infection,
localized edema (swelling), rash, pain, constipation, skin ulcers,
hypokalemia (low potassium levels), hypoalbuminemia (low albumin
levels), hyponatremia (low sodium levels), and dysphagia
(difficulty swallowing).
Other potential adverse effects associated with the use of
Optune Lua include treatment related skin irritation, allergic
reaction to the adhesive or to the gel, overheating of the array
leading to pain and/or local skin burns, infections at site where
the arrays make contact with the skin, local warmth and tingling
sensation beneath the arrays, medical device site reaction, muscle
twitching, and skin breakdown/skin ulcer. Talk to your doctor if
you have any of these side effects or questions.
About Tumor Treating Fields
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. These multiple, distinct
mechanisms work together to target and kill cancer cells. Due to
these 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 TTFields 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, malignant pleural mesothelioma and 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
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 “could,” “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.
_________________________ 1 World Health Organization Lung
Cancer Fact Sheet. Accessed October 3, 2024.
https://www.who.int/news-room/fact-sheets/detail/lung-cancer#:~:text=Lung%20cancer%20is%20the%20leading%20cause%20of%20cancer-related%20deaths%20worldwide,
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version on businesswire.com: https://www.businesswire.com/news/home/20241015381082/en/
Investors: Ingrid Goldberg investorinfo@novocure.com
Media: Catherine Falcetti media@novocure.com
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