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Novocure™ Announces Data Presentations at the World Federation of Neuro-oncology Societies 5th Quadrennial Meeting

NVCR | May 1, 2017

Novocure™ Announces Data Presentations at the World Federation of Neuro-oncology Societies 5^th Quadrennial Meeting

Analysis showing patients treated with Optune® in combination with temozolomide for newly diagnosed glioblastoma reported an unprecedented five-year survival advantage to be shared during an oral presentation

Novocure (NASDAQ: NVCR) announced today that ten data presentations investigating the use of Tumor Treating Fields (TTFields) for the treatment of glioblastoma will be presented at this year’s World Federation of Neuro-oncology Societies (WFNOS) 5^th Quadrennial Meeting in Zurich from May 4-7.

The listing of TTFields presentations at WFNOS include:

(OS07.9) Standard of care temozolomide chemotherapy ± Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma. Final results of the phase III EF-14 clinical trial. R. Stupp. Saturday, May 6, 11:50 a.m. – 12:00 p.m. CET. Location: Kongresssaal.
(P08.17) Mitotic checkpoint inhibition augments Tumor Treating Fields (TTFields) effects on glioblastoma cells. C. Hagemann. Friday, May 5, 5:00 p.m. – 6:00 p.m. CET. Location: Poster section P08.
(P09.07) The use of programmable shunts in patients treated with Tumor Treating Fields: multicentric case series. C.F. Freyschlag. Friday, May 5, 5:00 p.m. – 6:00 p.m. CET. Location: Poster section P09a.
(P09.12) Durable remission with Tumor Treating Fields as adjuvant treatment for glioblastoma relapse in a patient with grade IV hematotoxicity during initial temozolomide radiochemotherapy. C. Hirt. Friday, May 5, 5:00 p.m. – 6:00 p.m. CET. Location: Poster section P09a.
(P09.21) Complete radiological response after subtotal resection in two glioblastoma patients treated with Tumor Treating Fields. A.F. Kessler. Friday, May 5, 5:00 p.m. – 6:00 p.m. CET. Location: Poster section P09a.
(P09.23) Tumor Treating Fields delivery using second generation Optune system for glioblastoma treatment: patient experience and compliance. Friday, May 5, 5:00 p.m. – 6:00 p.m. CET. Location: Poster section P09a.
(P09.47) Long-term survival after Tumor Treating Fields (TTFields) therapy. A. Rulseh. Saturday, May 6, 6:00 p.m. – 7:00 p.m. CET. Location: Poster section P09b.
(P09.32) High therapy compliance in patients treated with Optune therapy does not depend on demographic data, stage of disease or treatment duration. M. Misch. Saturday, May 6, 6:00 p.m. – 7:00 p.m. CET. Location: Poster section P09b.
(P09.44) One year with Optune in Austria: first report on clinical experiences. D. Pinggera. Saturday, May 6, 6:00 p.m. – 7:00 p.m. CET. Location: Poster section P09b.
(P09.51) Simultaneous application of TTFields (Optune) and radiation in a 60-year old male patient: a case report. S. Scharl. Saturday, May 6, 6:00 p.m. – 7:00 p.m. CET. Location: Poster section P09b.

In addition, Novocure will have an exhibit where WFNOS attendees can meet with commercial and medical colleagues and learn more about Optune and Tumor Treating Fields (TTFields). Novocure will also host a scientific lunchtime symposium on Friday, May 5 from 12:35 to 2:00 p.m. CET in the main auditorium.

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.