Phase 2 pilot PANOVA data presented at the American Association for
Cancer Research Annual Meeting 2017
Progression free survival and one-year survival rate of patients
treated with Tumor Treating Fields plus nab-paclitaxel and gemcitabine
were more than double those of nab-paclitaxel and gemcitabine-treated
historical controls
ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today results from the second cohort
of its phase 2 pilot PANOVA trial studying Tumor Treating Fields
(TTFields) in combination with nab-paclitaxel and gemcitabine for the
treatment of advanced pancreatic cancer. These results will be presented
(Abstract CT130) on Tuesday, April 4 at the American Association for
Cancer Research Annual Meeting 2017 in Washington, D.C.
The PANOVA trial was a prospective, single-arm study testing the
feasibility, safety and preliminary efficacy of Tumor Treating Fields
(TTFields) in patients with advanced pancreatic cancer whose tumors
could not be removed surgically and who had not received chemotherapy or
radiation therapy prior to the clinical trial. The second cohort
included 20 patients who received a combination treatment regimen of
TTFields plus nab-paclitaxel and gemcitabine.
Median progression free survival in the TTFields-treated group was 12.7
months (compared to 5.5 months in nab-paclitaxel plus gemcitabine
historical controls) and median overall survival was not yet reached.
The median overall survival was not reached and the one-year survival
rate was 72 percent (compared to 35 percent in nab-paclitaxel plus
gemcitabine historical controls). Forty percent of the evaluable tumors
had partial responses (compared to 23 percent with nab-paclitaxel plus
gemcitabine alone) and another 47 percent had stable disease (compared
to 27 percent with nab-paclitaxel plus gemcitabine alone). Patients
reported no serious adverse events related to TTFields.
“Pancreatic cancer kills more than 300,000 individuals each year
worldwide. As the vast majority of pancreatic cancer cases are diagnosed
during the late stages, patients with advanced disease are in dire need
of additional treatment options,” said Dr. Manuel Benavides, Chief
Medical Oncologist at the Hospital Universitario Regional y Virgen de la
Victoria in Málaga, Spain. “The phase 2 pilot results look promising,
and I look forward to further study of TTFields in pancreatic cancer.”
Novocure is in the final stages of protocol development for a phase 3
pivotal trial studying TTFields in combination with nab-paclitaxel and
gemcitabine as a first-line treatment for locally advanced,
nonresectable, pancreatic cancer. The company anticipates it will enroll
the first patient in the second half of 2017 with data available for
presentation approximately 18 months following last patient enrollment.
“We are extremely pleased with these results,” said Dr. Eilon Kirson,
Novocure’s Chief Science Officer and Head of Research and Development.
“These data give us hope that TTFields used in combination with other
cancer treatments may increase survival without significantly increasing
side effects for a variety of solid tumors.”
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. 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 centered on 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 a research
center in Israel. For additional information about the company, please
visit www.novocure.com
or follow us at www.twitter.com/novocure.
Forward-Looking Statements
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statements provide Novocure’s current expectations or forecasts of
future events. These may include statements regarding anticipated
scientific progress on its research programs, development of potential
products, interpretation of clinical results, prospects for regulatory
approval, manufacturing development and capabilities, market prospects
for its products, and other statements regarding matters that are not
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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,
regulatory and political conditions as well as more specific risks and
uncertainties facing Novocure such as those set forth in its Annual
Report on Form 10-K filed on February 23, 2017, 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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Source: Novocure