FDA-Cleared GammaTile Therapy Offers New Option for Patients with Recurrent Meningiomas
TEMPE, Ariz.–(BUSINESS WIRE)–GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced positive results from a clinical trial supporting the efficacy and safety profile of a new treatment, GammaTile™ Therapy, for patients with recurrent, previously treated brain tumors known as meningiomas. Meningiomas are the most common type of primary brain tumor. They are usually non-cancerous but can have a significant impact on patients’ lives, causing headaches, seizures, cognitive decline, and other life-threatening symptoms. Results were published in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons.
In this single-arm, prospective study, 20 recurrent meningiomas were treated with adjuvant GammaTile Therapy immediately following surgery. The study found that in patients undergoing surgery followed by GammaTile, there was a statistically significant improvement in time-to-local disease progression (TTP) compared to the same patients’ prior rounds of treatment. At the time of the analysis, median TTP for tumors treated with GammaTile had not been reached because less than half of the patients had experienced tumor recurrence. Median TTP for tumors treated with GammaTile is projected to be at least 29 months (95 percent confidence interval) – nearly a year longer than results for prior rounds of treatment (18.3 months TTP, HR=0.17, p=0.02). At 18 months post-treatment, tumors had not recurred in 89 percent of patients treated with GammaTile, compared to 50 percent for prior rounds of treatment without GammaTile. Treatment with GammaTile was well tolerated.
GammaTile is an FDA-cleared, surgically targeted radiation therapy (STaRT™) for patients with recurrent intracranial neoplasms (brain tumors) including primary (benign or malignant) and metastatic tumors. Placed directly at the site of the tumor cavity during the last few minutes of excision surgery, GammaTile Therapy is a new approach that immediately begins targeting residual tumor cells, before they can replicate. Designed to help protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source.
GammaTile Therapy offers advantages over the most common treatment for patients undergoing surgery for recurrent brain tumors: a course of External Beam Radiation Therapy (EBRT), which requires daily treatments for up to six weeks. Some patients may not be candidates for EBRT. Once the disease has returned, many people with recurrent brain tumors have already received levels of radiation therapy that make the risk of additional external beam radiation outweigh the potential benefits. Additionally, those patients who are potentially candidates for EBRT typically have to wait two weeks or more for surgical wound healing before beginning treatment, giving any residual tumor cells a chance to replicate.
“In patients with recurrent meningiomas, treatment options are extremely limited. Repeat surgery may not be a good option without an effective adjuvant therapy. With GammaTile, we can now offer patients who otherwise would not have been able to receive treatment or who would likely be facing early recurrence another option – one proven to delay local meningioma tumor progression out to two years,” said Peter Nakaji, M.D., co-author of the study and GT MedTech’s co-founder and director of the Neurosurgery Residency Program at Barrow Neurological Institute. “Because it is delivered directly to the tumor bed, GammaTile offers the benefits of radiation while minimizing damage to surrounding healthy tissue from EBRT, and reduces the need for patients to return for daily outpatient radiation treatments.”
Because the therapy is implanted at surgery, patients treated with GammaTile Therapy require no additional trips to the hospital or clinic for radiation therapy. The therapy is targeted, so patients receive radiation only where it is needed and may receive a lower overall level of exposure of normal tissue to radiation. GammaTile Therapy can emit two-and-a-half times the radiation dose compared to the dose that can be achieved from EBRT. This dose is delivered to a localized area and is highly lethal to residual tumor cells.
Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year.1 Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with brain tumors have improved little over the past 30 years. Recurrence of brain tumors is common, and about half of all patients treated for brain tumors have their disease recur within a year.
“As a treating physician, I have seen first-hand the need for better options for our patients. We created GammaTile as a therapy designed to be immediate, safe, predictable, and effective,” said GT MedTech’s co-founder and chief technology officer David G. Brachman, M.D., lead author of the study, who previously served as chairman and medical director of Radiation Oncology at St. Joseph’s Hospital and Barrow Neurological Institute in Phoenix, Ariz. “These first published clinical data on the technology demonstrate that GammaTile is an effective therapy option that significantly delays the progression of this common brain tumor type.”
GammaTile Therapy received FDA 510(k) regulatory clearance for the treatment of all types of recurrent brain tumors in July 2018. The data published in JNS are the initial results of a larger basket-design study that looked at the use of GammaTile in 108 patients with several kinds of recurrent brain tumors, including gliomas and brain metastasis.
Dr. Brachman continued, “We are encouraged by these data in meningiomas and look forward to sharing data on the use of this treatment in other aggressive brain tumor types in the near future.”
About GT Medical Technologies, Inc.
Driven to overcome the limitations of current treatments for recurrent brain tumors and raise the standard of care, a team of brain tumor specialists joined forces and formed GT Medical Technologies with a purpose to prevent disease progression and improve quality of life for patients with recurrent brain tumors. Extensive clinical expertise informed the design of GammaTile Therapy, and deep medical device experience guides the company. The company is headquartered in Tempe, Arizona. For more information, visit https://www.gtmedtech.com/.
1 http://www.cbtrus.org/factsheet/factsheet.html, accessed December 27, 2018