ROADS Phase 3 Clinical Trial Data Presented at ASCO26 Show GammaTile® Provides Superior Tumor Control Leading to Patients Living Longer Without Recurrence Compared to Standard of Care in Newly Diagnosed Operable Brain Metastases

Results support GammaTile (cesium-131 collagen tile-based radiation therapy, or TBRT) as a new
standard of care for achieving optimal outcomes in this patient population

Superior efficacy achieved without increased side effects

Data presented in late-breaking abstract at the 2026 Annual Meeting of the American Society of
Clinical Oncology (ASCO26)

TEMPE, Ariz., May 30, 2026 /PRNewswire/ -- GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, today announced compelling new clinical data presented at ASCO26 from the randomized, multicenter ROADS trial (NCT04365374). The trial showed that patients who received surgery with GammaTile^® cesium-131 collagen tile-based radiation therapy (TBRT) were more likely to survive longer without recurrence compared to the current standard of care that is surgery plus stereotactic radiation therapy (SRT) for patients with newly diagnosed operable brain metastases. The data were reported in a late-breaking abstract at ASCO26.¹

GammaTile, an FDA-cleared, bioabsorbable collagen implant embedded with encapsulated radioisotope, is indicated for the treatment of operable malignant or recurrent brain tumors. GammaTile is placed in the tumor bed at the time of tumor removal surgery and immediately provides highly targeted radiation therapy to address residual tumor cells. This closes the critical gap that exists in conventional care – patients typically must wait weeks between surgery and radiation therapy.

The data show that the 12-month rate of tumor surgical bed recurrence was dramatically lower with GammaTile TBRT (1.0%) compared with SRT (11.9%).¹ Surgical bed recurrence-free survival, defined as the time from surgery to either tumor recurrence or death from any cause, whichever occurred first, was significantly improved with GammaTile TBRT (median not reached) compared with SRT (10.9 months).¹

What do the co-lead investigators say about the ROADS data?
The multicenter ROADS trial was co-led by Jeffrey Weinberg, MD, professor of Neurosurgery, and Thomas H. Beckham, MD, PhD, assistant professor of CNS Radiation Oncology at The University of Texas MD Anderson Cancer Center.

"Surgery is the primary treatment for operable brain metastases, but tumor cells that are invariably left behind can lead to recurrence," said Dr. Weinberg. "Radiation therapy plays a critical role in eliminating these residual cells, and the ROADS data show that TBRT outperforms SRT with respect to tumor control, recurrence and overall survival. These results are well beyond what we have come to expect with SRT, and they support TBRT as the radiation therapy approach of choice for patients with newly diagnosed operable brain metastases."

"The ROADS data convincingly show the benefit of beginning radiation therapy at the time of surgery for patients with newly diagnosed operable brain metastases," said Dr. Beckham. "These findings should support broader adoption of TBRT in this patient population."

How did patients benefit from GammaTile in the ROADS trial?
The phase 3 trial randomized 230 patients across 32 centers, with operable brain metastases to GammaTile or SRT following surgery to remove the tumor.¹

• GammaTile showed superior performance in the study's co-primary endpoints¹
  • GammaTile demonstrated lower rates of surgical bed regrowth (SBR) at 12-months compared to standard radiation therapy (1.0% vs. 11.9%).
  • Patients who received GammaTile had a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care [SRT] (HR: 0.48, p=0.002).

• GammaTile provided benefit in key secondary endpoints¹
  • The superior efficacy did not come at the cost of increased toxicity or worsened quality of life.
    • Functional status, quality of life, time to distant brain failure, adverse events, leptomeningeal disease and radiation necrosis were similar in the GammaTile and SRT arms.
  • Overall survival was significantly improved with GammaTile. Estimated 24-month overall survival was 61.7% for GammaTile compared with 35.7% for SRT (HR: 0.59 p=0.032).
  • GammaTile demonstrated significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups proving GammaTile delivers superior outcomes without added risk.

• GammaTile patients completed all cranial management for the operable tumor in a median of 1 day, compared to 30 days for patients receiving standard radiation therapy (p<0.001)¹

"The randomized prospective data from 230 patients across 32 centers around the U.S. should give clinicians the confidence in offering GammaTile for brain metastases needing surgical resection," explained Dr. Michael Garcia, MD, MS, Chief Medical Officer of GT Medical Technologies. "These patients have faced important challenges with existing treatment approaches, and ROADS now delivers the high level of evidence to support GammaTile as a new up-front treatment option for these patients."

What are the limitations of standard of care in operable brain metastases?
Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life.² Standard treatment for operable brain metastases is surgery to remove the tumor and, after 3-8 weeks of surgical recovery, delivery of SRT. Tumor cells remaining after surgery can regrow in the period before initiating SRT, and the 1-year tumor recurrence rate with this regimen is 28%.^3. In addition, patient adherence to prescribed radiation regimens remains a persistent challenge: published data show that approximately 20% of patients do not complete their full prescribed course of post-operative radiation therapy.^4,5

"GT Medical was founded to address unmet treatment needs for patients with operable brain tumors," says Per Langoe, Chief Executive Officer of GT Medical Technologies. "We believe that these highly compelling results will help to drive expanded adoption of GammaTile as a standard of care for newly diagnosed operable brain metastases and other operable brain tumors."

What is tile-based radiation therapy (TBRT) with GammaTile?
GammaTile is an FDA-cleared, bioabsorbable collagen implant embedded with the radioisotope cesium-131, designed for patients with operable brain tumors. Each GammaTile is about the size of a postage stamp (2 cm x 2 cm) and contains evenly spaced seeds filled with cesium-131 that emit low-dose rate radiation over several weeks.⁶ GammaTile is used to line the cavity that remains after the tumor has been removed, ensuring even distribution of radiation across the surface of the cavity and precise targeting of remaining tumor cells. This highly localized approach targets remaining cancer cells when they are at their lowest levels to help prevent tumor regrowth.⁶ The emitted radiation only travels a short distance, which maximizes dosing to the tumor cavity while protecting surrounding healthy brain tissue.⁷

Is GammaTile commercially available?
GammaTile is FDA-cleared for newly diagnosed malignant (cancerous) and recurrent brain tumors and has been adopted by more than 150 leading centers across the United States, underscoring its growing acceptance in both academic and community healthcare settings.⁸ For more information, visit gammatile.com and follow @GammaTile on Facebook, Instagram, LinkedIn and X.

About GT Medical Technologies, Inc.
GT Medical Technologies was founded by a dedicated team of brain tumor specialists to address unmet needs in brain tumor treatment. The company is committed to improving the lives of patients with brain tumors through innovative solutions that elevate the standard of care.

Media Contact
Alyssa Paldo
FINN Partners
[email protected]
646-813-3174

References

1. Weinberg J. J Clin Oncol 44, 2026 (suppl 17; abstr LBA2000).
2. Lamba N, Wen PT, Aizer AA. Epidemiology of brain metastases and leptomeningeal disease. Neuro-Oncology. 2021;23(9):1447-1456.
3. Mahajan A, Ahmed S, McAleer MF, et al. Prospective randomized trial of post-operative stereotactic radiosurgery versus observation for completely resected brain metastases. Lancet Oncol. 2017;18(8):1040-1048.
4. Yeboa DN, Li J, Lin R, et al. Therapy, safety, and logistics of preoperative vs postoperative stereotactic radiation therapy: a preliminary analysis of a randomized clinical trial (NCT03741673). JAMA Oncol. 2025;11(8):890–899.
5. Brennan C, Yang TJ, Hilden P, et al. A phase 2 trial of stereotactic radiosurgery boost after surgical resection for brain metastases. Int J Radiat Oncol Biol Phys. 2014;88:130–136.
6. Garcia MA, Turner A, Brachman DG. The role of GammaTile in the treatment of brain tumors: a technical and clinical overview. J Neurooncol. 2024;166:203-212.
7. Kutuk T, Kotecha R, Herrera R, et al. Surgically targeted radiation therapy versus stereotactic radiation therapy: A dosimetric comparison for brain metastasis resection cavities. Brachytherapy. 2024:23(6):751-760.
8. Data on file. GT Medical Technologies, Inc.

SOURCE GT Medical Technologies