A phase 3 pivotal trial – PANOVA-3 – will test the efficacy of
TTFields with gemcitabine and nab-paclitaxel as a front-line treatment
of locally advanced pancreatic cancer
ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today that the company will present
three abstracts studying Tumor Treating Fields (TTFields) in pancreatic
cancer at the European Society for Medical Oncology 19th
World Congress on Gastrointestinal Cancer on June 28 through July 1 in
Barcelona. Among the highlights is an abstract that will outline the
trial design for PANOVA-3, Novocure’s phase 3 pivotal study of TTFields
with gemcitabine and nab-paclitaxel as a front-line treatment of locally
advanced pancreatic cancer.
PANOVA-3, a prospective, randomized trial, will include 600 patients
with unresectable locally advanced pancreatic cancer. Patients should
have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 and no
prior progression or treatment. Experimental-arm patients will use a
TTFields delivery system tuned to 150 kHZ for at least 18 hours a day
until the disease progresses. Follow up, including a CT scan of the
chest and abdomen, will be performed every eight weeks. Patients who
progress will be followed monthly for survival. The primary endpoint is
overall survival. The secondary endpoints are progression-free survival,
objective response rate, rate of resectability, quality of life and
toxicity.
“We are excited to present our trial design for PANOVA-3. We accelerated
the trial design after learning the results for our phase 2 pilot study
of TTFields plus nab-paclitaxel and gemcitabine in patients with
advanced pancreatic cancer, which more than doubled progression free
survival and the one-year survival rate versus nab-paclitaxel and
gemcitabine-treated historical controls,” said Dr. Eilon Kirson,
Novocure’s Chief Science Officer and Head of Research and Development.
“Pancreatic cancer kills more than 300,000 individuals each year
worldwide. We are hopeful that TTFields combined with standard of care
chemotherapy could potentially reduce metastasis and tumor size in these
patients, making more patients candidates for resection. We hope to
deliver better patient outcomes and address this unmet need.”
The following abstracts will be presented at the European Society for
Medical Oncology 19th World Congress on Gastrointestinal Cancer:
PANOVA-2: A phase 2 study of TTFields (150 kHz) concomitant with
standard chemotherapy for front-line therapy of advanced pancreatic
adenocarcinoma – Updated efficacy results; M. Benavides, C. Guillen, F.
Rivera, J. Gallego, J.A. Lopez-Martin, M. Küng; Thursday, June 29;
abstract: #315
PANOVA-3: A phase 3 study of TTFields with gemcitabine and
nab-paclitaxel for front-line treatment of locally-advanced pancreatic
adenocarcinoma (LAPC); Uri Weinberg, Ori Farber, Moshe Giladi, Ze'ev
Bomzon, Eilon Kirson; Thursday, June 29; abstract: P-230
A simulation-based study on the distribution of TTFields in the body
when treating pancreatic cancer; Cornelia Wenger, Ofir Yesharim, Ariel
Naveh, Hadas Hershkovich, Uri Weinberg and Ze'ev Bomzon; Thursday, June
29; abstract: #335
TTFields are not approved for the treatment of pancreatic cancer by the
U.S. Food and Drug Administration. The safety and effectiveness of
TTFields therapy for pancreatic cancer has not been established.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the
U.S. The American Cancer Society estimated that about 53,000 people
would be diagnosed with pancreatic cancer and about 42,000 people would
die from the disease in 2016. Worldwide, more than 330,000 people die
from the disease every year. Five-year survival among patients with
metastatic pancreatic cancer is 2 percent.
About Novocure
Novocure is an oncology company developing a profoundly different cancer
treatment utilizing a proprietary therapy called TTFields, the use of
electric fields tuned to specific frequencies to disrupt solid tumor
cancer cell division. Novocure’s commercialized product, Optune, is
approved for the treatment of adult patients with glioblastoma. Novocure
has ongoing or completed clinical trials investigating TTFields in brain
metastases, non-small cell lung cancer, pancreatic cancer, ovarian
cancer and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New
Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the
company has offices in Germany, Switzerland and Japan, and Israel. For
additional information about the company, please visit www.novocure.com
or follow us at www.twitter.com/novocure.
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Therefore, you should not rely on any such factors or forward-looking
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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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Source: Novocure