ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today that four data presentations on Tumor Treating Fields (TTFields) will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress, September 8 through September 12 in Madrid, Spain. Among the highlights is a poster discussion of the overall survival and quality of life data from Novocure’s two phase 3 pivotal trials in patients with glioblastoma (GBM), EF-14 in newly diagnosed GBM patients and EF-11 in recurrent GBM patients.
In the EF-14 trial, the combination of TTFields with temozolomide led to a significant extension of overall survival versus temozolomide alone without added systemic toxicity. The addition of TTFields to temozolomide delayed decline in several health-related quality of life scales compared to temozolomide alone. The addition of TTFields to temozolomide did not negatively impact quality of life for newly diagnosed GBM patients except for causing itchy skin.
The following abstracts will be presented at the ESMO 2017 Congress:
- (334PD) Tumor Treating Fields (TTFields) – A novel cancer treatment modality: Translating preclinical evidence and engineering into a survival benefit with delayed decline in quality of life. R. Stupp. Saturday, September 9, 4:30 – 5:30 p.m. Location: Bilbao Auditorium.
- (759P) PANOVA: A phase II study of TTFields (150 kHz) with concomitant standard chemotherapy for front-line advanced pancreatic adenocarcinoma – Updated efficacy results. M. Küng. Saturday, September 9, 1:15 – 2:15 p.m. Location: Hall 8.
- (782TiP) PANOVA-3: A phase 3 study of TTFields with gemcitabine and nab-paclitaxel for front-line treatment of locally advanced pancreatic adenocarcinoma (LAPC). O. Farber. Saturday, September 9, 1:15 – 2:15 p.m. Location: Hall 8.
- (1206P) Efficacy of Tumor Treating Fields (TTFields) and anti-PD-1 in non-small cell lung cancer (NSCLC) preclinical models. M. Giladi. Sunday, September 10, 1:15 – 2:15 p.m. Location: Hall 8.
Approved Indications
In the United States, Optune is
intended as a treatment for adult patients (22 years of age or older)
with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial GBM following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In Europe, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In Europe, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at [email protected] in Europe.
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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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, 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 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, 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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