Novocure Announces Six Clinical Presentations on Novocure’s Phase 3 Pivotal EF-14 Trial Data in Newly Diagnosed Glioblastoma at 22nd Annual Meeting of the Society for Neuro-Oncology
An oral presentation will focus on how compliance and treatment duration may predict survival in newly diagnosed glioblastoma patients treated with Optune® together with temozolomide
In total, 54 abstracts on Tumor Treating Fields, including two oral presentations, will be presented
The volume of Tumor Treating Fields presentations marks a record number of abstracts
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today six clinical presentations on Novocure’s phase 3 pivotal EF-14 trial data in newly diagnosed glioblastoma (GBM) at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO), November 16 through November 19, in San Francisco. A total of 54 abstracts on Tumor Treating Fields, including two oral presentations, will be presented at the conference. The volume of Tumor Treating Fields presentations marks a record number of abstracts at SNO and demonstrates what we believe to be a growing interest in Novocure’s cancer treatment among researchers and clinicians throughout the world.
“Year after year, we continue to see an increase in the number of abstracts on Tumor Treating Fields accepted for presentation at the SNO Annual Meeting, the premier neuro-oncology conference,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are honored to have the opportunity to share our growing volume of data and eager to see the presentations on Tumor Treating Fields by external researchers”
The six clinical presentations include an oral presentation by Zvi Ram, MD, Director of Neurosurgery at the Tel-Aviv Sourasky Medical Center in Tel-Aviv, focusing on how compliance and treatment duration may predict survival in newly diagnosed GBM patients treated with Optune® together with temozolomide. Additionally, the presentations will highlight other learnings from the EF-14 trial dataset on the effects of Optune on health-related quality of life, time to functional and cognitive decline, analyses by Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) scores, patterns of Optune-related severe skin toxicity, and the use of Optune as a second-line treatment after first recurrence.
“Novocure’s EF-14 trial is the largest positive trial completed to date in newly diagnosed GBM and the trial dataset continues to provide new opportunities to deepen our understanding of Tumor Treating Fields in order to improve treatment outcomes for GBM patients,” said Dr. Ram. “I look forward to sharing some of the latest findings with the scientific community at the SNO Annual Meeting.”
Oral presentation of EF-14 clinical trial data
(ACTR-27) Compliance and treatment duration predict survival in a phase 3 trial of tumor treating fields with temozolomide in patients with newly diagnosed glioblastoma. Z. Ram. 4:15 – 4:20 p.m. PDT on Friday, November 17. (Location: 3A Adult Clinical Trials II)
Poster presentations of EF-14 clinical trial data
(QLIF-25) Effect of Tumor Treating Fields (TTFields) on health-related quality of life (HRQoL) in newly diagnosed glioblastoma. Results of the EF-14 randomized phase III trial. M. Taphoorn. 7:30 p.m. to 9:30 p.m. PDT Friday, November 17. (Location: Golden Gate ballroom, B2 level)
(NCOG-05) Time to functional and cognitive decline in a phase 3 trial of tumor treating fields with temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma. G. Nicholas. 7:30 p.m. to 9:30 p.m. PDT Friday, November 17. (Location: Golden Gate ballroom, B2 level)
(ACTR-55) Tumor treating fields with second line treatment compared to second line treatment alone in patients at first recurrence of glioblastoma – a post hoc analysis of the EF-14 phase 3 clinical trial. S. Kesari. 5 to 7 p.m. PDT Saturday, November 18. (Location: Golden Gate ballroom, B2 level)
(ACTR-39) Application of RTOG-RPA scores in a phase 3 trial of tumor treating fields with temozolomide (TTFields/TMZ) versus temozolomide (TMZ) alone in newly diagnosed glioblastoma. K. Choe. 5 to 7 p.m. PDT Saturday, November 18. (Location: Golden Gate ballroom, B2 level)
(ACTR-10) Patterns of TTFields-related severe skin toxicity in GBM patients. F. Lieberman. 5 to 7 p.m. PDT Saturday, November 18. (Location: Golden Gate ballroom, B2 level)
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.
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.
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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