GammaTile

New Phase 3 Results

From the ROADS Randomized Controlled Trial

NEWLY Dx OPERABLE BRAIN METS
As Presented at the 2026 ASCO® Annual Meeting1
FOR MEDIA PARTNERS
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GammaTile® tile-based
radiation therapy (TBRT) demonstrates
improved patient outcomesimproved
patient
outcomes
compared to standard of care: resection + post-operative
stereotactic radiation therapy (SRT).1

Key Finding1

As Presented at the 2026 ASCO® Meeting (Late-breaking Abstract)

Immediate, targeted radiation at the time of surgery
reduces the risk of recurrence or death by >50% vs. standard of care1

HR: 0.48, p=0.0021

Co-Primary Endpoints

Superior

Surgical Bed Recurrence-Free Survival

(HR: 0.48; 95% CI: 0.30–0.76; p=0.0021)1

Superior

Time to Surgical Bed Recurrence

(HR: 0.06; 95% CI: 0.01–0.46; p=0.0070)1

Secondary Endpoints

Longer

Overall Survival

(HR: 0.59; 95% CI: 0.37–0.96; p=0.032)1

Comparable

Safety

RN, LMD, ≥ Grade 3 TRAE1

GammaTile demonstrates
superior efficacy
compared to standard of care1

Cumulative incidence of surgical bed recurrence
at 12 months

Resection + GammaTile
1.3%
Resection + SRT
15.4%

HR: 0.07; 95% CI: 0.01–0.56; p=0.012

Chart: cumulative incidence of surgical bed recurrence (%) over 24 months since surgery. R+TBRT remains near 0% while R+SRT rises to approximately 30%. HR: 0.07; 95% CI: 0.01–0.56; p=0.012.

Co-Primary Endpoints

GammaTile demonstrated superior time to surgical bed recurrence (SBR)1

Time-to-SBR = Time from surgery to SBR

Median time to SBR

Resection + GammaTile
NOTreached
Resection + SRT
17.4months

HR: 0.06; 95% CI: 0.01–0.46; p=0.0070

Chart: probability of remaining SBR free (%) over 24 months since surgery. The GammaTile arm remains near 100% while the SRT arm declines to below 50%. HR: 0.06; 95% CI: 0.01–0.46; p=0.0070.

GammaTile demonstrated superior surgical bed
recurrence-free survival (SB-RFS)1

SB-RFS = Time from surgery to either SBR or death from any cause, whichever occurred first

Median SB-RFS

Resection + GammaTile
NOTreached
Resection + SRT
10.9months

HR: 0.48; 95% CI: 0.30–0.76; p=0.0021

Chart: probability of freedom from SB-RFS events (%) over 24 months since surgery. The R+TBRT arm remains higher than the R+SRT arm throughout. HR: 0.48; 95% CI: 0.30–0.76; p=0.0021.

Secondary Endpoints

Overall survival (OS) was longer with GammaTile1

OS = Time from surgery to death from any cause

Median OS

Resection + GammaTile
42.5months
Resection + SRT
17.6months

HR: 0.59; 95% CI: 0.37–0.96; p=0.032

Chart: probability of overall survival (%) over 24 months since surgery. The R+TBRT arm remains higher than the R+SRT arm throughout. HR: 0.59; 95% CI: 0.37–0.96; p=0.032.

Safety1

There were no statistically significant differences among safety endpoints1,2

p-valueR + TBRTR + SRT
Radiation necrosis (RN)1p=0.765.3%5.7%
24-mo probability of being alive without LMD2p=0.1057.7%35.9%
Leptomeningeal disease (LMD)2p=0.149.7%3.0%
All ≥ Grade 3 treatment-related adverse events (TRAEs)1NR20.0%21.7%
Radiation necrosis (RN)1
p-value: p=0.76
R + TBRT: 5.3%
R + SRT: 5.7%
24-mo probability of being alive without LMD2
p-value: p=0.10
R + TBRT: 57.7%
R + SRT: 35.9%
Leptomeningeal disease (LMD)2
p-value: p=0.14
R + TBRT: 9.7%
R + SRT: 3.0%
All ≥ Grade 3 treatment-related adverse events (TRAEs)1
p-value: NR
R + TBRT: 20.0%
R + SRT: 21.7%

Study Design1

Patients enrolled:

Total enrollment: 230

mITT population: 204*

Total sites:

Multi-center, 32

Median resected tumor diameter,

cm (range)

TBRT: 3.20 (2.0–6.1)

SRT: 3.25 (2.1–5.8)

Mean number of brain metastases,

(standard dev)

TBRT: 1.8 (1.13)

SRT: 1.8 (1.23)

SRT Arm Fractions:

1: 7.8%

3-5: 92.2%

Co-Primary Outcomes**,†
  • Time-to-surgical bed recurrence (time-to-SBR)
  • Surgical bed recurrence-free survival (SB-RFS)
Secondary Outcomes
  • Overall survival (OS)
  • Functional status (KPS, Barthel-ADL)
  • Quality of life (FACT-Br)
  • Adverse events
  • Development of leptomeningeal disease (LMD)†
  • Assessment of radiation necrosis (RN)
  • Factors that cause delays in SRT

* Pre-specified modified intent-to-treat (mITT) population was used for efficacy analyses. mITT = patients who had surgery, pathologic confirmed metastasis, any follow up information

** SBR = radiographic evidence of new or progressive contrast-enhancing metastasis within the surgical bed

† All reported SBR and LMD confirmed by central review by two independent neuroradiologists

ROADS Protocol1

‡ Note: Study participants in both arms may have additional brain tumors that are not suitable for surgical removal (1-5 additional non-surgical brain metastases). These remaining tumors will be treated with SRT. SRT = Stereotactic Radiation Therapy

See more clinical evidence supporting the use of GammaTile for operable brain tumors.
REFERENCES: 1. Weinberg J. ROADS: A randomized controlled phase 3 trial of resection plus post-operative stereotactic radiation versus resection plus cesium-131 tile-based radiation therapy for newly diagnosed brain metastases. Presented at: American Society of Clinical Oncology; May 30, 2026; Chicago, IL. 2. Weinberg J, et al., J Clin Oncol 44, 2026 (suppl 17; abstr LBA2000).
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