Long-term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirm...
September 12 2016 - 7:00AM
Business Wire
Data demonstrate superior two, three and four
year survival of patients treated with Optune™ together with
temozolomide
Novocure (NASDAQ:NVCR) announced today that long-term survival
analysis of the full 695 patient dataset from the phase 3 pivotal
EF-14 trial of Optune in combination with temozolomide for the
treatment of newly diagnosed glioblastoma (GBM) will be presented
as a late-breaking oral presentation at the 21st Annual Scientific
Meeting of the Society for Neuro-Oncology (SNO) in Scottsdale,
Arizona, on Friday, Nov. 18, 2016.
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Martin Romero Sanchez of Houston, Texas,
is an Optune patient.
The long-term survival analysis of the full and mature dataset
confirms the interim analysis results published in the Journal of
the American Medical Association (JAMA)1 in December 2015, showing
significant extension of both progression free and overall survival
in newly diagnosed GBM patients receiving Optune with temozolomide
compared to temozolomide alone. The long-term analysis shows
survival rates were significantly higher four years from
randomization in patients receiving Optune with temozolomide
compared to patients receiving temozolomide alone. The safety
profile in the mature analysis was consistent with the interim
analysis of the EF-14 trial.
“The analysis of the mature dataset provides an impressive
confirmation of the improvement in both progression free and
overall survival we saw in the trial’s interim analysis results,
and demonstrates the trial met its prespecified endpoints at both
interim and long-term analyses,” said Roger Stupp, M.D., Professor
at the University of Zurich and Director of Department of Oncology
at the Zurich University Hospital, Zurich, Switzerland and EF-14
Principal Investigator. “I look forward to sharing the data with
the scientific community in November.”
About Novocure
Novocure is a commercial-stage oncology company developing a
novel, proprietary therapy called Tumor Treating Fields, or
TTFields, for the treatment of solid tumor cancers. 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 Haifa, Israel. For additional information
about the company, please visit www.novocure.com or
follow us at www.twitter.com/novocure.
Approved Indications
Optune is intended as a treatment for adult patients (22 years
of age or older) with histologically-confirmed glioblastoma
multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult
patients with newly diagnosed, supratentorial glioblastoma
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.
Full prescribing information is available at
www.optune.com/safety or by calling toll free 1-855-281-9301.
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 March 1, 2016, 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.
1 Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy
with tumor-treating fields plus temozolomide vs temozolomide alone
for glioblastoma: a randomized clinical trial. JAMA.
2015;314(23):2535-2543.
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version on businesswire.com: http://www.businesswire.com/news/home/20160912005496/en/
Media and Investors:NovocureAshley Cordova,
212-767-7558acordova@novocure.com
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