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)–
“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.
The six clinical presentations include an oral presentation by
“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 –
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.
(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.
(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.
(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.
(ACTR-10) Patterns of TTFields-related severe skin toxicity in GBM patients. F. Lieberman.
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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
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.
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