ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today that the final analysis of its phase 3 pivotal trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) has been published in the Journal of the American Medical Association (JAMA). The final analysis proved that overall survival and progression free survival were each significantly extended by 37 percent for patients who received Optune plus temozolomide compared to patients who received temozolomide alone. The analysis demonstrated a greater than one in eight chance of five-year survival for patients with newly diagnosed GBM treated with the Optune and temozolomide. The statistically significant benefit of Optune with temozolomide on overall survival was seen in all pre-specified patient subgroups, regardless of prognostic factors such as age, performance status, MGMT promotor methylation and extent of resection.
“This is the first positive phase 3 trial in newly diagnosed GBM since the efficacy of temozolomide was demonstrated in 2005,” said EF-14 Investigator Jay-Jiguang Zhu, M.D., Ph.D., Director of Neuro-Oncology at UTHealth and Memorial Hermann Hospital, McGovern Medical School, in Houston. “The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long term survival. The results demonstrated that Tumor Treating Fields are an effective antimitotic treatment modality, which could change the way we treat a variety of solid cancers in the future.”
The multi-national, randomized, open-label trial included 695 newly diagnosed GBM patients who were enrolled at 83 centers from July 2009 to December 2016. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone (HR, 0.63; 95 percent Cl, 0.53-0.76; P<.001), confirming and improving upon the results of the interim analysis of the trial published in JAMA in 2015.
The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase 3 trial to date and represent a new landmark for five-year survival rate in this difficult to treat disease.
The overall survival benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups including subgroups with the worst prognosis who have benefitted less from previous therapies – patients 65 years of age or older and patients with unmethylated MGMT promoter. There was no increase in systemic adverse events from Optune plus temozolomide versus temozolomide alone. The only common adverse reaction from Optune treatment noted in the final analysis was mild to moderate skin irritation beneath the system’s transducer arrays.
“GBM is a very difficult to treat disease where over 20 large randomized phase 3 studies have failed to show a survival benefit over the past decade. We are proud of the EF-14 final analysis and what it means to patients living with GBM,” said Novocure CEO Asaf Danziger. “We are honored to have the final analysis published in such a prestigious medical journal and believe it will help us to continue to effectively educate the medical community about the benefits of Optune with temozolomide for the treatment of newly diagnosed GBM.”
About Novocure
Novocure is an oncology company developing a profoundly different cancer treatment utilizing 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 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, 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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