Increased compliance with Optune predicted survival in Novocure’s phase 3 pivotal EF-14 trial in newly diagnosed glioblastoma

An Optune compliance threshold as low as 50 percent correlated with significantly improved outcomes in patients treated with Optune together with temozolomide versus patients treated with temozolomide alone

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ:NVCR) announced today results from a retrospective post-hoc analysis of its phase 3 pivotal EF-14 trial data showing that increased compliance with Optune predicted increased survival in glioblastoma (GBM) patients. Results were highlighted in an oral presentation at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO) in San Francisco.

The analysis showed that an Optune compliance threshold as low as 50 percent correlated with significantly improved outcomes in patients treated with Optune together with temozolomide compared to patients treated with temozolomide alone. The results also demonstrated that the greater patients’ compliance with Optune, the better their outcomes. Patients who used Optune more than 90 percent of the time (n=43) had the greatest chance of survival: a median survival of 24.9 months from randomization and a five-year survival of 29.3 percent. The median time from diagnosis to randomization was 3.8 months for patients treated with Optune together with temozolomide.

“Increased compliance with Optune led to increased survival in GBM,” said Zvi Ram, MD, Director of Neurosurgery at the Tel-Aviv Sourasky Medical Center in Tel-Aviv, who presented the data at SNO. “These data show that nearly one in three GBM patients in the EF-14 trial who were more than 90 percent compliant with Optune reached five-year survival. Compliance with Optune matters and changed the course of the disease for many GBM patients. I feel honored to share these insightful data.”

Novocure’s phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival (PFS) and overall survival (OS). The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.

Patients in the EF-14 trial treated with Optune together with temozolomide were recommended to use Optune 75 percent of the time, or 18 hours per day. This new analysis demonstrated that a threshold value as low as 50 percent compliance with Optune led to an extension of both PFS (n= 62, HR 0.70, 95 percent CI 0.47–1.05) and OS (n= 62, HR 0.67, 95 percent CI 0.45–0.99) versus temozolomide alone. As compliance increased to 75 percent or greater, the survival benefit significantly increased (p=0.031). Patients who used Optune 70-80 percent of the time had a median survival of 21.7 months (n= 91). Patients who used Optune more than 90 percent of the time had the greatest chance of survival: a median survival of 24.9 months from randomization and a five-year survival of 29.3 percent (>90 percent compliance: n= 43, PFS HR 0.54, 95 percent CI 0.37–0.79; OS HR 0.52, 95 percent CI 0.35–0.79). The median time from diagnosis to randomization was 3.8 months for patients treated with Optune together with temozolomide. The data also show that increased compliance independently predicted survival and was not affected by prognostic factors such as performance status, age or MGMT methylation.

“We are pleased with this latest analysis showing that GBM patients who were the most compliant with Optune had the greatest chance of five-year survival,” said Novocure CEO Asaf Danziger. “We are committed to further exploring our EF-14 data with the hopes of improving treatment outcomes in GBM.”

About Novocure

Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called Tumor Treating Fields, 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 Tumor Treating Fields 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, Japan and 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.

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.

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.

Patients should only use Optune under the supervision of a physician properly trained in use of the device.

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