Novocure Announces Favorable Independent Data Monitoring Committee Recommendation to Continue Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer
July 21 2023 - 8:00AM
Business Wire
Pre-specified interim analysis concluded that the fully enrolled
PANOVA-3 clinical trial should proceed to final analysis as
planned
Novocure (NASDAQ: NVCR) today announced the results of a
pre-specified interim analysis for the phase 3 PANOVA-3 clinical
trial evaluating the safety and efficacy of Tumor Treating Fields
(TTFields) therapy together with nab-paclitaxel and gemcitabine for
the treatment of patients with unresectable, locally advanced
pancreatic cancer. An independent data monitoring committee (DMC)
reviewed the safety and efficacy data for all patients in the fully
enrolled clinical trial. The interim analysis resulted in a DMC
recommendation that the clinical trial proceed to final
analysis.
“Completion of the interim analysis with the DMC’s
recommendation to continue PANOVA-3 to completion marks another
important step in pursuit of our mission to treat patients with
difficult solid tumors of the abdomen,” said Asaf Danziger,
Novocure’s Chief Executive Officer. “I would like to express my
thanks to our patients and investigators. We look forward to
reviewing the PANOVA-3 data in 2024 and potentially extending the
lives of patients diagnosed with deadly locally advanced pancreatic
cancer by treating with our novel therapy, Tumor Treating
Fields.”
About PANOVA-3
PANOVA-3 is a randomized, open-label clinical trial designed to
enroll 556 adult patients with unresectable, locally advanced
pancreatic adenocarcinoma. Patients have been randomized to receive
either the combination of nab-paclitaxel and gemcitabine
concomitant with TTFields therapy tuned to 150 kHz until
progression or the combination of nab-paclitaxel and gemcitabine
alone. The primary endpoint is overall survival. Secondary
endpoints include progression free survival, local progression free
survival, objective response rate, one-year survival rate, quality
of life, pain-free survival, puncture-free survival, resectability
rate, and toxicity. Following enrollment of the final patient in
February 2023, patients will be followed for a minimum of 18
months.
About Pancreatic Cancer
Pancreatic cancer is one of the most lethal cancers and is the
third most frequent cause of death from cancer in the U.S. While
overall cancer incidence and death rates are remaining stable or
declining, the incidence and death rates for pancreatic cancer are
increasing. It is estimated that approximately 53,000 patients are
diagnosed with pancreatic cancer each year in the U.S. Pancreatic
cancer has a five-year relative survival rate of just 10%.
Physicians use different combinations of surgery, radiation and
pharmacological therapies to treat pancreatic cancer, depending on
the stage of the disease. For patients with locally advanced
pancreatic cancer involving encasement of arteries but no
extra-pancreatic disease, the standard of care is surgery followed
by chemotherapy with or without radiation. Unfortunately, the
majority of locally advanced cases are diagnosed once the cancer is
no longer operable, generally leaving chemotherapy with or without
radiation as the only treatment option.
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.
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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610-723-7427
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