On October 2, 2023 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported interim findings of a multi-institutional study that demonstrates high local control for the treatment of recurrent brain metastases in patients, adding to the growing evidence of the efficacy and safety of its FDA-approved GammaTile Therapy at the American Society for Radiation Oncology’s (ASTRO) 65th Annual Meeting (Press release, GT Medical Technologies, OCT 2, 2023, View Source [SID1234635574]).
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The meeting is taking place October 1 to 4, 2023, at the San Diego Convention Center.
At this interim timepoint, 48 patients with 51 brain metastases at 14 U.S. sites were treated with GammaTile, a treatment that provides immediate radiation where it is needed most after brain tumor removal surgery. None of the patients experienced adverse effects from the radiation treatment in follow-ups, which had a median time of four months post-surgery.
"We could not have achieved these interim clinical results without the support of the doctors and patients who were part of this registry study from across the nation," said study author David Brachman, MD, Co-founder and the Chief Technology Officer of GT Medical Technologies. "This robust emerging scientific data reinforces the impact GammaTile Therapy has on local control for patients with brain metastases. It builds upon an already strong body of evidence that shows just how effective and safe GammaTile is for patients with brain tumors."
Dr. Brachman, MD presented the clinical findings of GammaTile during a poster viewing Q&A session on Monday, October 2, 2023. The poster, titled: "Surgically Targeted Radiation Therapy (STaRT) for Brain Metastases: Initial Experience from a Prospective Multi-institutional Registry" will be available on the ASTRO Annual Meeting Portal.
"As an enrolling institution in the GTM-101 registry, we are excited by these initial interim results demonstrating the feasibility of GammaTile brachytherapy for patients with brain metastases – with a median implantation time of 3 minutes – and no patients experiencing any radiation-attributed adverse effects," said Rupesh Kotecha, MD, lead study author and Chief of Radiosurgery for the Department of Radiation Oncology at Miami Cancer Institute, Baptist Health South Florida, Miami, FL.
GammaTile is a Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms, including primary (benign or malignant) and metastatic tumors.
In addition to the poster presented at the ASTRO Annual Meeting, three recently published clinical studies from Memorial Sloan Cancer Center, Barrow Neurological Institute and Miami Cancer Institute further demonstrated that GammaTile leads to durable local control for the treatment of recurrent brain metastases.
Among these three publications, Miami Cancer Institute’s findings were recently published in Brachytherapy on September 16, 2023. The results showed that GammaTile for operable recurrent brain metastases was associated with superior local control compared to the first course of external beam radiotherapy in the series. Study authors found the initial clinical experience demonstrated that GammaTile is associated with a high local control rate, modest surgical complication rate, and low radiation necrosis risk in the reirradiation setting.
Members of GT Medical Technologies team will be available to discuss the study’s implications for patients along with the recent published studies on GammaTile at Booth 2723.
Since its initial FDA clearance in 2018 for recurrent brain tumors and subsequent FDA clearance in 2020 for newly diagnosed brain tumors, GammaTile Therapy has helped more than 1,000 people with operable brain tumors.
The incidence of brain metastasis is increasing with an estimated 98,000 to 170,000 cases each year. And is likely increasing as a result of patients with systemic metastatic disease are surviving longer as a result of new innovations like immunotherapy.