Oncologists in 2019 may begin offering patients with pleural mesothelioma a novel, tumor-fighting tool involving electric currents that enhance standard-of-care treatment and extend survival, according to the device manufacturer.
Tumor Treating Fields (TTF) is the name of the new technology. It is designed to disrupt cancer cell division through electric fields tuned to specific frequencies.
In an ongoing multicenter phase II clinical trial in Europe, TTF has shown an ability in first-line treatment to improve the effectiveness of standard chemotherapy for mesothelioma patients.
The trial success has led the manufacturer to accelerate the FDA approval application process, expecting to receive a Humanitarian Device Exception (HDE) that could start its use for mesothelioma in the United States.
Novocure, which manufactures and markets the device, is a global oncology company based in the United Kingdom, with operations in the U.S., Israel, Japan, Switzerland and Australia.
“Pending approval [by the FDA], we are planning to make it available in 2019,” Dr. Eilon Kirson, chief science officer and head of research and development at Novocure, told Asbestos.com. “This could make a big difference for mesothelioma patients, in a clinically meaningful, significant way.”
Already Successful with Brain Cancer
The Tumor Treating Fields technology already has been approved by the FDA. It is used for the treatment of glioblastoma, an aggressive form of brain cancer.
The National Comprehensive Cancer Network (NCCN), in its latest guidelines, recommends TTF in newly diagnosed patients with glioblastoma.
Treatment in the phase II clinical trial for mesothelioma requires patients to wear four electrically insulated electrode arrays across the chest and back.
It is a battery-powered, take-home device that is worn continuously, allowing patients to maintain a regular daily routine. Patients are expected to keep the device active for at least 18 hours each day.
TTF works synergistically with chemotherapy to selectively disrupt cell division.
Clinical Trial Signals Advancement
The trial, designed to study the safety and efficacy of the medical device, has included 80 patients across seven European countries who also are receiving chemotherapy(pemetrexed and either cisplatin or carboplatin).
An interim analysis of the first 42 patients, reported 18 months ago, included a one-year survival rate of 79.7 percent. The median progression-free survival was 7.3 months.
A median overall survival had not yet been reached.
By comparison, historical controls used in the study included a 50 percent one-year survival and 5.7-month progression-free survival for those receiving the same chemotherapy combination without the TTF device.
Kirson declined to provide the updated data, preferring to release them in an upcoming presentation as part of the FDA application process.
“I can say the data is very compelling. The final results of the study are looking extremely promising,” he said. “The progression-free survival will go up. The median overall survival is much better than you’d expect. We are extremely pleased with these top-line results.”
No Toxic Side Effects
The side effects were minimal, mostly skin irritation from wearing the electrodes. No device-related toxicity has been reported.
Novocure also has completed — or has ongoing clinical trials — involving Tumor Treating Fields for brain metastasis, ovarian cancer, pancreatic cancer and non-small cell lung cancer.
Each tumor type utilizes different intensity and frequency field settings with varying array sizes based on location.
Mesothelioma is the first torso cancer for which Novocure has applied for FDA approval.
“We hope people will start hearing about it beyond the neurological oncology realm,” he said. “Now with mesothelioma, we’re hoping it’s something that oncologists in general, radiation oncologists, will be aware of. There is another therapy that can be used in addition to the standard modality of surgery, radiation and pharmacology.”
Kirson believes TTF has played a significant role in the survival rates of patients with glioblastoma, which has more than doubled in the last decade. He is hoping for a similar result with mesothelioma.
“This is not going to change the way mesothelioma is treated. We’re adding to the existing standard of care,” he said. “We see it as a large, significant tool we are providing patients and doctors to treat this disease and change patient outcomes. It could make a big difference.”