GammaTile Reduces Brain Metastases Recurrence Risk by Over 50% in Phase 3 ROADS Trial

GT Medical Technologies查看公司主页 announced breakthrough interim results from its phase 3 ROADS clinical trial, demonstrating that GammaTile (搜索)搜索该药品 significantly outperforms standard of care for patients with newly diagnosed operable brain metastases. The randomized controlled trial, which completed enrollment of 230 patients across 30 leading cancer centers in the United States, showed that immediate radiation therapy at the time of surgery reduces the risk of tumor recurrence or death by greater than 50% compared to current treatment approaches.

Trial Design and Patient Population

The ROADS trial (Randomized Controlled Trial of Resection and GammaTile (搜索)搜索该药品 versus Standard of Care) evaluated whether implanting GammaTile—a bioabsorbable collagen implant embedded with radiation seeds—could improve outcomes compared with surgery followed by postoperative external beam stereotactic radiation therapy (SRT). The trial was led by Dr. Thomas Beckham, Assistant Professor in the Department of Radiation Oncology, and Dr. Jeffrey Weinberg, Professor of Neurosurgery and Deputy Chair at The University of Texas MD Anderson Cancer Center.

Patients were randomly assigned on a 1:1 basis to receive either surgical resection plus GammaTile (搜索)搜索该药品 therapy or surgery plus standard of care stereotactic radiation therapy. Eligible participants included patients 18 years and older with 1 to 6 newly diagnosed brain metastases, one primary index lesion planned for surgical resection, and a Karnofsky performance status of at least 70.

Superior Efficacy Results

The pre-planned interim analysis, conducted on 168 enrolled patients and presented at the 2025 Congress of Neurological Surgeons, revealed significant improvements across multiple endpoints. GammaTile (搜索)搜索该药品 demonstrated superiority in the primary endpoint of surgical bed recurrence-free survival, with patients living longer without tumor regrowth and experiencing a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care (hazard ratio 0.42, p=0.0024).

Additionally, GammaTile (搜索)搜索该药品 showed superiority in overall protection from worrisome radiographic brain changes, including both tumor recurrence and radiation-related tissue damage. At the time of analysis, more than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while in the SRT group, more than half of patients had already experienced one of these events by 16 months (hazard ratio of 0.32, p=0.018).

Safety Profile and Treatment Approach

The interim data demonstrated that GammaTile (搜索)搜索该药品 achieved significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups, proving that GammaTile delivers superior outcomes without added risk.

"Although the ROADS trial focused on patients with operable brain metastases, the study reflects real-world treatment patterns, where many patients have a large metastasis that needs surgery and small brain metastases that can be well managed with stereotactic radiation without removal," said Dr. Weinberg. "In such cases, patients randomized to the GammaTile (搜索)搜索该药品 arm received GammaTile radiation for the operable tumor and stereotactic radiation for the small metastases."

Addressing Treatment Gaps in Brain Metastases

Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life. For patients with operable tumors, surgery followed by external beam stereotactic radiation has been the standard of care, yet its limitations are well recognized, with a 1-year tumor recurrence rate of 28%. Additionally, up to one third of patients miss or delay postoperative radiation due to access barriers, fragmented care pathways, or logistical challenges.

GammaTile (搜索)搜索该药品 is designed to overcome these shortcomings by delivering immediate, targeted, and continuous radiation directly into the surgical cavity at the time of tumor removal. This approach ensures that radiation therapy begins when microscopic cancer cells are most vulnerable—immediately after surgery, at the lowest point of tumor burden—and guarantees that every patient receives radiation treatment.

Clinical Significance and Future Impact

"The interim data from the ROADS trial is the first randomized, multicenter evidence showing the superiority of starting radiation immediately at the time of tumor removal with GammaTile (搜索)搜索该药品 for operable brain metastases," said Dr. Michael Garcia, Chief Medical Officer at GT Medical Technologies查看公司主页. "These results highlight the importance of immediate, targeted radiation therapy."

Dr. Weinberg and his colleague Dr. Beckham noted that these interim results suggest this approach not only achieves local control but does so with superiority over the existing standard of care, potentially redefining treatment approaches for this disease.

Since its full market launch in the United States in March 2020, GammaTile (搜索)搜索该药品 has been adopted by more than 100 leading centers, demonstrating growing acceptance in both academic and community healthcare settings. The technology provides immediate radiation when and where it is needed most, offering the potential to transform outcomes for patients with operable brain tumors while giving patients and clinicians confidence that treatment begins immediately at tumor removal.