GammaTile® Demonstrates Promising Tumor Control in Newly Diagnosed Brain Metastases

A recent multicenter Phase IV registry study has revealed compelling evidence on the clinical efficacy of GammaTile® therapy in managing newly diagnosed brain metastases. Conducted by GT Medical Technologies, the study involved 51 patients treated at various centers, all of whom received surgical resection followed by GammaTile implantation.

The findings, published in the Journal of Neuro-Oncology, highlighted a significant 92.3% local tumor control rate at 12 months post-treatment. This therapeutic approach also demonstrated a low cumulative incidence of leptomeningeal disease (LMD) at 7.8%, while maintaining an overall Grade 3 toxicity rate of 9.8%, with no reported cases of radiation necrosis.

GammaTile® delivers targeted radiation immediately post-surgery, allowing for prompt treatment of residual microscopic disease. Matthew J. Shepard, MD, a neurosurgery assistant professor and senior author of the study, commented, "Delivering radiation at the time of surgery allows us to treat the resection cavity immediately, when residual microscopic disease is the lowest. These prospective registry data show very high local control and a low incidence of leptomeningeal disease. Importantly, the observed safety profile was consistent with expected routine postoperative management."

With a median follow-up period of 12.4 months, the study confirmed the safety and effectiveness of GammaTile® as an integrated part of postoperative care. Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies, noted that the results "add to important real-world evidence supporting GammaTile as a safe and effective immediate adjuvant radiation therapy."

As GammaTile targets remaining cancer cells immediately following their surgical reduction, it helps in curbing potential regrowth while minimizing radiation exposure to surrounding healthy tissue. This approach marks a significant advancement in bridging the treatment gap between surgical resection and radiation therapy.

While the study's insights are substantial, the authors acknowledge its descriptive nature and call for further research. Upcoming randomized trials, such as the ongoing ROADS study (NCT04365374), aim to provide additional clarity regarding the incorporation of GammaTile into therapeutic regimens for brain metastases.

GammaTile®, since its market debut in the United States in March 2020, has gained traction across over 100 medical centers, indicating its growing acceptance and contribution to improving patient outcomes in brain tumor management.