Novocure (NASDAQ: NVCR) today announced that the phase 3
ENGOT-ov50 / GOG-3029 / INNOVATE-3 clinical trial of Tumor Treating
Fields (TTFields) together with paclitaxel in patients with
platinum-resistant ovarian cancer did not meet its primary endpoint
of overall survival (OS) at the final analysis. Patients randomized
to receive TTFields therapy plus paclitaxel (n=280) demonstrated a
median OS of 12.2 months versus a median OS of 11.9 months in
patients treated with paclitaxel alone (n=278) (HR: 1.008).
Consistent with previously reported studies, TTFields therapy was
well-tolerated with no added systemic toxicities.
“Recurrent ovarian cancer is a particularly aggressive cancer
and options for patients diagnosed with platinum-resistance remain
extremely limited,” said Ignace Vergote, MD, PhD, Principal
Investigator and Chairman of the Belgium and Luxembourg
Gynaecological Oncology Group and Professor at the Catholic
University of Leuven, Belgium. “We are committed to continuing
research with TTFields and exploring innovative approaches to treat
this area of immense unmet need, and we are extremely grateful to
all the investigators and patients for their participation in these
studies.”
The ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial enrolled patients
with a maximum of five total prior lines of systemic therapy. An
analysis of exploratory subgroups suggests a potential survival
benefit in patients who received only one prior line of therapy.
This signal could merit further exploration given the unmet need
for the ~20% of ovarian cancer patients who have a limited response
to frontline platinum-based treatment. Full evaluation of the data
from the ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial, including
subgroup analyses, is ongoing.
“While the final results of the ENGOT-ov50 / GOG-3029 /
INNOVATE-3 trial differ from our initial expectation, these data
add important context to the treatment paradigm,” said David
O’Malley, MD, Professor of Obstetrics and Gynecology at The Ohio
State University Wexner College of Medicine and Director of the
Division of Gynecologic Oncology at The James Comprehensive Cancer
Center. “We see treatment exposure and number of prior therapies
are relevant and can drive outcomes, and we will leverage these
data as we explore and identify new opportunities to treat this
deadly disease.”
“The INNOVATE-3 clinical trial set out to harness the unique
mechanisms of Tumor Treating Fields to extend survival in
platinum-resistant ovarian cancer,” said William Doyle, Novocure’s
Executive Chairman. “While today’s update is disappointing, we are
encouraged by the signal identified from the exploratory analysis
which suggests the potential for a clinical benefit when TTFields
therapy is initiated early in a patient’s treatment journey. We are
deeply grateful to the patients who participated in this clinical
trial, their loved ones, and to the trial investigators.”
Novocure will work with investigators to share the full results
with the scientific community.
About ENGOT-ov50 / GOG-3029 / INNOVATE-3 The ENGOT-ov50 /
GOG-3029 / INNOVATE-3 clinical trial was designed to evaluate the
safety and effectiveness of TTFields together with paclitaxel in
patients with platinum-resistant ovarian cancer. The primary
endpoint of INNOVATE-3 was overall survival. Secondary endpoints
include progression-free survival, objective response rate,
severity and frequency of adverse events, time to undisputable
deterioration in health-related quality of life or death, and
quality of life. Enrollment in the trial closed in October 2021
with 540 patients enrolled, beginning the minimum 18-month
follow-up period.
The European Network for Gynaecological Oncological Trial groups
("ENGOT") and The GOG Foundation, Inc. ("GOG"), third-party
clinical trial networks, collaborated with Novocure on the trial.
Both ENGOT and GOG were involved in the development and
facilitation of the trial at leading cancer centers in Europe and
the United States.
About Ovarian Cancer In the U.S., ovarian cancer ranks
fifth in cancer deaths among women, with approximately 24,000 women
diagnosed each year. Ovarian cancer incidence increases with age,
and the median age at time of diagnosis is 63 years old.
Physicians use different combinations of surgery and
pharmacological therapies to treat ovarian cancer, depending on the
stage of the disease. Surgery is usually used in early stages of
the disease and is usually combined with chemotherapy, including
paclitaxel and platinum-based chemotherapy. Unfortunately, the
majority of patients are diagnosed at an advanced stage when the
cancer has spread outside of the ovaries to include regional tissue
involvement and/or metastases. Platinum-based chemotherapy remains
part of the standard of care in advanced ovarian cancer, but most
patients with advanced ovarian cancer will have tumor progression
or, more commonly, recurrence. Almost all patients with recurrent
disease ultimately develop platinum resistance, and the prognosis
for this population remains poor.
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 PARP inhibition 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, 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.
About ENGOT and BGOG (https://engot.esgo.org
and www.bgog.eu) The European Network of
Gynaecological Oncology Trial groups (ENGOT) is a platform that
guarantees that the European spirit and culture is incorporated
into the medical progress in gynaecological oncology, and that all
European patients and countries can participate in an active way in
clinical research and progress. The ultimate goal is to bring the
best treatment to gynecological cancer patients through the best
science and enabling every patient in every European country to
access a clinical trial. The Belgium and Luxembourg Gynaecological
Oncology Group (BGOG) is one of the founding study groups of
ENGOT.
About The GOG Foundation, Inc. (GOG-F)
(www.gog.org) The GOG Foundation, Inc. is a
not-for-profit organization with the purpose of promoting
excellence in the quality and integrity of clinical and
translational scientific research in the field of gynecologic
malignancies. The GOG Foundation is committed to maintaining the
highest standards in clinical trials development, execution,
analysis, and distribution of results. The GOG Foundation is the
only clinical trialist group in the United States that focuses its
research on patients with pelvic malignancies, such as cancer of
the ovary (including surface peritoneal malignancies), uterus
(including endometrium, soft tissue sarcoma, and gestational
trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is
multi-disciplinary in its approach to clinical trials, and includes
gynecologic oncologists, medical oncologists, pathologists,
radiation oncologists, oncology nurses, biostatisticians (including
those with expertise in bioinformatics), basic scientists, quality
of life experts, data managers, and administrative personnel.
About GOG Partners Program Supported by industry, GOG
Partners is structured to work directly with pharmaceutical
organizations and operate clinical trials outside the National
Cancer Institute (NCI) framework. The GOG Partners Program shares
the same mission of the GOG Foundation dedicated to transforming
the care in Gynecologic Oncology. By providing an alternative venue
for patient accrual and site infrastructure support, GOG Partners
has helped provide additional trials and opportunities for patients
outside the national gynecologic clinical trials network.
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 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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610-723-7427
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