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Long-Term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival Rates

Al's Comment:

 This is what we have been waiting for. The final results of the Optune trial for newly diagnosed GBM.  There was some resistance to accepting Optune as the standard of care because the results presented 2 years ago were "just preliminary". The final results are actually better than the preliminary results!

Now the next step is getting insurance to pay for it. Already most non-Medicare plans do pay for it, but Medicare has been hesitating. We had a petition a while ago to help nudge Medicare toward paying for it.  I presented it to them and we did come close and I think it did help - but we had that problem of results being preliminary.  We are going to try again. I resurrected the survey - and updated it to show current results.  Please sign it and have your friends and family members sign it.  IF you already signed it last time - you do not need to sign it again - it is still valid.  If you aren't sure, email me your name and address and I will check it for you.  Go to https://virtualtrials.com/activism.cfm for details and to sign! 


Posted on: 11/18/2016

 

 

 
Source: http://www.novocure.com/long-term-analysis-of-all-695-patients-enrolled-in-novocures-phase-3-pivotal-trial-in-newly-diagnosed-glioblastoma-confirms-successful-interim-analysis-results-and-demonstrates-superior-two/

 

Long-Term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival Rates

 

 

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that a long-term analysis of the
full trial cohort from its phase 3 pivotal EF-14 trial of Optune® in
combination with temozolomide for the treatment of newly diagnosed
glioblastoma (GBM) confirmed the superior survival results seen at
interim analysis. The long-term analysis demonstrated superior two-,
three- and four-year survival of patients treated with Optune together
with temozolomide compared to temozolomide alone. The interim analysis
results – published in the Journal of the American Medical
Association (JAMA) 1 in December 2015 – showed
significant extension of both progression free and overall survival in
newly diagnosed GBM patients receiving Optune with temozolomide compared
to temozolomide alone.

EF-14 Principal Investigator Roger Stupp, M.D., Professor at the
University of Zurich and Director of Department of Oncology at the
Zurich University Hospital, Zurich, Switzerland, will present these late
breaking results at the 21st Annual Scientific Meeting of the
Society for Neuro-Oncology (SNO) on Nov. 18, in Scottsdale, Arizona.

“The analysis of the full dataset confirms the improvement in both
progression free and overall survival we saw in the trial’s interim
analysis, and demonstrates superior long-term survival,” Dr. Stupp said.
“These mature results further validate Optune as a standard of care
treatment option for glioblastoma, providing patients with a therapy
that can extend their survival while maintaining their quality of life.”

“We are excited that Novocure’s long-term analysis of the EF-14 trial
confirms the interim analysis results of superior overall and
progression free survival, while providing new data on potential
long-term survival benefits for newly diagnosed GBM patients,” said
Elizabeth M. Wilson, President and CEO of the American Brain Tumor
Association. “GBM patients need better treatment options, and it is a
great day when new evidence shows that we are making progress in
treating this disease.”

The long-term analysis of all patients (n=695) shows that:

Patients treated with Optune together with temozolomide demonstrated a
significant increase in median progression free survival (PFS)
compared to temozolomide alone (median PFS of 6.7 months versus 4.0
months, respectively, hazard ratio=0.63, p=0.00005).

Patients treated with Optune together with temozolomide demonstrated a
significant increase in median overall survival (OS) compared to
temozolomide alone (median OS from randomization of 20.8 months versus
16.0 months, respectively, hazard ratio=0.65, p=0.0006)

The percentage of patients alive at two years in the Optune together
with temozolomide arm was 43 percent compared to 30 percent in the
temozolomide alone arm, a 43% increase in the chance of living two
years.

The percentage of patients alive at four years in the Optune together
with temozolomide arm was 17 percent compared to 10 percent in the
temozolomide alone arm, a 70% increase in the chance of living four
years.

Consistent with the interim analysis, the OS and PFS benefit of Optune
together with temozolomide compared to temozolomide alone was seen
across all patient subgroups tracked in the EF-14 trial, including
patient age, performance status and tumor genetics.

The safety profile in the long-term analysis was consistent with the
interim analysis of the EF-14 trial.

“The long-term analysis further supports our data showing that Optune
together with temozolomide is a better treatment option for newly
diagnosed GBM patients compared to temozolomide alone,” said Asaf
Danziger, Novocure’s CEO. “We believe these results will give health
care providers further confidence in our therapy and transform the
standard of care in newly diagnosed GBM. Our priority is to improve the
lives of GBM patients, and we believe these results will help us to
accomplish our mission.”

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. Novocure’s commercialized product,
Optune, is approved for the treatment of adult patients with
glioblastoma. Novocure has ongoing or completed phase 2 pilot trials
investigating TTFields in 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 Haifa, Israel. For additional information about the company,
please visit www.novocure.com
or follow us at www.twitter.com/novocure.

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
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.

Important Safety Information

Contraindications

Do not use Optune if you have an active implanted medical device, a
skull defect (such as, missing bone with no replacement), or bullet
fragments. Use of Optune together with implanted electronic devices has
not been tested and may theoretically lead to malfunctioning of the
implanted device. Use of Optune together with skull defects or bullet
fragments has not been tested and may possibly lead to tissue damage or
render Optune ineffective.

Do not use Optune if you are known to be sensitive to conductive
hydrogels. In this case, skin contact with the gel used with Optune may
commonly cause increased redness and itching, and rarely may even lead
to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Use Optune only after receiving training from qualified personnel, such
as your doctor, a nurse, or other medical personnel who have completed a
training course given by Novocure (the device manufacturer).

Do not use Optune if you are pregnant, you think you might be pregnant
or are trying to get pregnant. It is not known if Optune is safe or
effective in these populations.

The most common (≥10%) adverse events involving Optune in combination
with temozolomide were low blood platelet count, nausea, constipation,
vomiting, fatigue, scalp irritation from device use, headache,
convulsions, and depression.

The most common (≥10%) adverse events seen when using Optune alone were
scalp irritation from device use and headache.

The following adverse reactions were considered related to Optune when
using the device alone: scalp irritation from device use, headache,
malaise, muscle twitching, fall and skin ulcer.

All servicing procedures must be performed by qualified and trained
personnel.

Do not use any parts that do not come with the Optune Treatment Kit, or
that were not sent to you by the device manufacturer or given to you by
your doctor.

Do not wet the device or transducer arrays.

If you have an underlying serious skin condition on the scalp, discuss
with your doctor whether this may prevent or temporarily interfere with
Optune treatment.

Please see http://www.optune.com/safety to
see the Optune Instructions For Use (IFU) for complete information
regarding the device’s indications, contraindications, warnings, and
precautions.

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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