Data suggest combined modality treatment with TTFields and triplet combination chemotherapy may extend survival in patients with recurrent glioblastoma

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that four abstracts focusing on Tumor Treating Fields (TTFields) will be presented at the upcoming 69^th American Academy of Neurology (AAN) annual meeting on April 22-28, in Boston. All four abstracts were submitted by external researchers, representing a growing interest in Novocure’s proprietary TTFields therapy.

Among the highlights is a presentation on the overall survival benefits of TTFields in combination with triplet combination chemotherapy for recurrent glioblastoma (GBM). Forty-six patients at The University of Texas Health Center in Houston were identified who received Optune, Novocure’s TTFields delivery system, at initial diagnosis or at recurrence from 2010 to 2016. At recurrence, 21 patients received Optune with a triplet combination chemotherapy regimen consisting of temozolomide, bevacizumab, and irinotecan and 25 patients received Optune with bevacizumab alone, bevacizumab plus irinotecan, or bevacizumab plus temozolomide. The median overall survival for patients receiving the combination of Optune plus triplet combination chemotherapy was 32.8 months and the median overall survival for patients receiving Optune plus the alternative chemotherapy regimen was 16.5 months, demonstrating a superior overall survival benefit when Optune was combined with triplet combination chemotherapy at recurrence. The side effect profiles for both patient populations was similar.

“We have seen in post-hoc analyses of our EF-14 phase 3 pivotal clinical trial data that GBM patients continued to benefit from treatment with Optune even after their disease recurred,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “Dr. Zhu’s research on the optimal combination chemotherapy regimen further strengthens our understanding on how to combine Optune with other cancer treatments to improve patient outcomes in GBM.”

The scheduled times of the presentations and locations at the Boston Convention and Exhibition Center are as follows:

Tumor Treating Fields with Triple Chemotherapy for Recurrent Glioblastoma

• Presenter: Jay-Jiguang Zhu
• Poster Session I: Neuro-oncology Gliomas I, Publication 177
• Sunday, April 23, 4:00-5:30 p.m. Eastern Time

Compliance of Tumor Treating Fields Therapy and Overall Survival in Glioblastoma

• Presenter: Eric Wong
• Poster Session I: Neuro-oncology Gliomas I, Publication 166
• Sunday, April 23, 4:00-5:30 p.m. Eastern Time

Analysis of Glioblastoma Physical Characteristics in Patients Benefiting from Tumor Treating Fields Therapy

• Presenter: Pyay San
• Poster Session I: Neuro-oncology Gliomas I, Publication 178
• Sunday, April 23, 4:00-5:30 p.m. Eastern Time

Tumor Treating Fields Distribution in Glioblastoma Volume Depends on Conductivity Parameters

• Presenter: Edwin Lok
• Poster Session V: Neuro-oncology Gliomas II, Publication 169
• Thursday, April 27, 5:30-7:00 p.m. Eastern Time

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

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.

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 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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Source: Novocure