The RTOG 3503 phase 2 pilot trial is the first consortium study to test treatment with Optune
ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure™ (NASDAQ: NVCR) announced today that the first patient has been enrolled in the RTOG Foundation’s phase 2 pilot trial testing Optune together with bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma (GBM).
Optune is an FDA-approved Tumor Treating Fields (TTFields) delivery system for the treatment of newly diagnosed and recurrent GBM. In recurrent GBM, both Optune and bevacizumab are approved as monotherapies. The current trial intends to test the efficacy and safety of Optune in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM.
“The results of this trial will provide additional information to the brain tumor research community on the safety and effectiveness of using Optune in combination with bevacizumab in patients with bevacizumab-refractory recurrent GBM,” said Dr. Manmeet Ahluwalia, Dean and Diane Miller Endowed Chair in NeuroOncology at Cleveland Clinic and Co-Principal Investigator of the trial. “These patients face a dismal prognosis and are in need of treatment options.”
The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at 20 institutions in the United States. Patients must have a recurrence or progression of GBM or other grade IV glioma after being treated with bevacizumab. The trial will determine the efficacy of Optune together with bevacizumab measured by overall survival at six months. Additional endpoints include overall and progression-free survival from time of registration, response rates, and toxicities of bevacizumab with Optune.
“This is the first consortium study of TTFields, demonstrating the continued and mounting interest in Optune from the scientific community,” said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. “Our EF-11 phase 3 pivotal trial in recurrent GBM patients suggested that in a subgroup of patients who were refractory to bevacizumab Optune monotherapy led to an extension in survival versus chemotherapy. We are excited that RTOG is researching the potential benefit of Optune together with bevacizumab in this difficult-to-treat population of patients.”
“For 40 years, RTOG has conducted studies designed to improve the survival and quality of life of cancer patients,” said Dr. Jeffrey J. Raizer, Co-Founding-Director of the Northwestern Brain Tumor Institute and Co-Principal Investigator of the trial. “RTOG is excited to partner with Novocure on this important study, and I am pleased to be able to offer Optune to patients in this study.”
For more information on the trial designs, visit clinicaltrials.gov and reference NCT02743078. Treatment with TTFields is not approved in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM has not been established.
About the RTOG Foundation
The RTOG Foundation, Inc., a nonprofit research organization, is an international leader in conducting practice-changing clinical trials involving advanced radiotherapy techniques and their combination with new classes of anti-cancer biomarker driven therapies. RTOG Foundation is the successor to the Radiation Therapy Oncology Group, a 40-year participant in the cooperative group program funded by the National Cancer Institute (NCI). RTOG’s mission then and now is to improve the survival and quality of life of cancer patients. RTOG trials employ translational research strategies to identify patient subgroups that are at risk for failure with existing treatments and identify new treatment options for these patients. RTOG designs and conducts NCI-funded trials as a founding member of NRG Oncology and collaborates with industry partners to identify and test promising new agents through multisite private sector trials. This trial is funded entirely through corporate support from Novocure and has not been approved by the NCI.
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, 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 and Japan, and a research center in 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.
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 visit Optune.com/Safety for Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
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.
