This trial is the first to study Optune in combination with an investigational drug
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today a new arm for a phase 1b study to evaluate the safety of marizomib and temozolomide in combination with Optune, Novocure’s Tumor Treating Fields (TTFields) delivery system, as adjuvant treatment for patients with newly diagnosed glioblastoma (GBM) following radiation therapy with concurrent temozolomide. The trial is the first to study Optune in combination with an investigational drug.
Marizomib is a novel, brain-penetrant proteasome inhibitor developed by Triphase Accelerator Corporation and acquired by Celgene Corporation. Celgene is responsible for marizomib’s development.
“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM,” said Principal Investigator Dr. Roger Stupp, Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “Optune is the first treatment in over a decade to improve survival in GBM. I believe that combining Optune with new pharmacologic treatments in clinical trials, like this phase 1b study, will help advance our understanding of how to treat this devastating disease.”
Celgene and Triphase modified their current phase 1b multicenter, open-label study of marizomib in combination with temozolomide and radiotherapy in patients with grade IV malignant gliomas to include Optune. A cohort of 12 GBM patients will be treated with Optune in combination with marizomib and temozolomide after initial treatment with radiation and temozolomide has been completed.
The primary objective for the Optune portion of the study is to determine the safety of the combination of marizomib and temozolomide with the addition of Optune in patients entering the adjuvant treatment phase. Secondary objectives for the Optune portion of the study include assessing preliminary clinical activity of the combination of Optune, marizomib and temozolomide in patients entering adjuvant therapy, progression-free survival and overall survival. The protocol has been submitted to an institutional review board, and this arm of the trial is expected to open in the third quarter of 2017.
“We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “As innovators in cancer treatment, we know collaboration is essential to improve patient outcomes. We hope this is the first collaboration of many.”
Tumor Treating Fields in combination with temozolomide and marizomib is experimental for the treatment of glioblastoma. Limited by law to investigational use only.
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, 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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, 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.
In the United States, 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.
Marizomib is an investigational, proteasome inhibitor initially developed by Triphase Accelerator Corporation and now owned by Celgene Corporation. Marizomib has been shown to irreversibly bind to all three proteasome subunits (β5 chymotrypsin-like, β2 trypsin-like, and β1 caspase-like). In early clinical trials, marizomib has demonstrated brain penetration activity. Marizomib is being developed in both intravenous (IV) and in early oral formulations as a potential proteasome inhibitor for hematologic malignancies and solid tumors. The IV formulation has been evaluated in more than 390 patients in multiple clinical studies in patients with solid and hematologic malignancies, including multiple myeloma either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, anti-angiogenic/anti-VEGF or an immunomodulatory drug. Marizomib is not approved in any country for any indications.
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Ashley Cordova, 212-767-7558