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Combination of Optune™ with Standard of Care Chemotherapy, Temozolomide, Delayed Decline in Several Health-Related Quality of Life Scales Compared to Temozolomide Alone for Newly Diagnosed Glioblastoma Patients

NVCR | May 8, 2017

Addition of Optune to temozolomide did not negatively impact quality of life for newly diagnosed glioblastoma patients except for causing itchy skin

Novocure™ (NASDAQ:NVCR) announced today results from health-related quality of life analyses from its phase 3, pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma. The data, presented at this year’s World Federation of Neuro-oncology Societies 5^th Quadrennial Meeting in Zurich, showed that Optune with temozolomide did not negatively impact health-related quality of life, except for itchy skin, which was most likely due to skin irritation beneath Optune’s transducer arrays. The combination treatment of Optune with temozolomide improved deterioration-free survival of several predefined health-related quality of life scales, compared to temozolomide alone, likely related to improved progression free and overall survival.

“Some physicians and patients have expressed concerns regarding the possible negative impact of Optune on patient quality of life” said Eilon Kirson, M.D., Ph.D., Novocure’s Chief Science Officer and Head of Research and Development. “The health-related quality of life analyses presented this weekend show conclusively that not only was quality of life not harmed by the use of Optune with temozolomide but deterioration in quality of life was delayed compared to temozolomide alone in several health related quality of life scales, most likely due to the longer progression free and overall survival of patients treated with Optune with temozolomide.”

Patients completed two validated health-related quality of life questionnaires (EORTC QLQ-C30 and BN20) at the beginning of the trial, and every three months thereafter. Health-related quality of life over time was assessed for nine preselected scales: global health, physical, cognitive, role, social and emotional functioning, itchy skin, pain and weakness of legs. The results were as follows:

More patients treated with the combination of Optune and temozolomide reported stable or improved scores on: global health status (53 percent versus 38 percent, p=.001), pain (57 percent versus 36 percent, p<.0001), physical functioning (54 percent versus 38 percent, p=.001) and leg weakness (59 percent versus 42 percent, p=.001) when compared to patients treated with temozolomide alone.
Deterioration-free survival (the time until quality of life declined by more than 10 points or disease progression) was longer (p<.01) for patients treated with the combination of Optune and temozolomide versus patients treated with temozolomide alone for: global health (4.8 versus 3.3 months), physical (5.1 versus 3.7 months) and emotional functioning (5.3 versus 3.9 months), pain (5.6 versus 3.6 months) and leg weakness (5.6 versus 3.9 months).
Time to deterioration (the time until quality of life declined by more than 10 points, excluding disease progression) did not significantly differ between treatment arms, except for itchy skin (8.2 months for patients treated with Optune plus temozolomide versus 14.4 months for patients treated with temozolomide alone, p<.001), and pain (13.4 months for patients treated with Optune plus temozolomide versus 12.1 months for patients treated with temozolomide alone, p<.001).
Health-related quality of life over time did not significantly differ between treatment arms except for itchy skin, which was worse with Optune plus temozolomide versus temozolomide alone, at three, six and nine months (p=.0004).

“This data further cements our belief that Optune plus temozolomide should be offered as an essential combination therapy to every newly diagnosed patient with glioblastoma,” said Asaf Danziger, Novocure’s CEO. “We are pleased to offer a treatment that may not only provide a survival benefit in terms of duration of life but also has the potential to provide stability or improvement in the quality of life during that time compared to the use of temozolomide alone.”

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.

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.

In the European Union, 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 the European Union, 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 supportEMEA@novocure.com in the European Union.

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 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.