Clinical Strategy

Radiation Therapy Consideration

  • Safely deliver radiation dose while minimizing side effects
  • Tolerance of healthy tissue dictates radiation dose
  • Often resulting in insufficient doses for long term benefit

Motion Management

Radiation Therapy Limitations

  • Patient anatomy changes from day to day — shape and size of tumor and surrounding organs
  • Intra-fraction motion — during treatment respiratory motion and changes in filling status
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Focused Clinical Strategy

ClinicalMan desktop
Breast
Prostate
Brain
Lung
Pancreas
Common Cancers
Tough-to-treat Cancers

Clinical Trial Results

ASTRO 2022
Phase II: SMART Pancreas (Tough-to-treat Cancer)

01
Study design
Phase II, single arm, multi-center, international, n=136
02
Treatment method
Ablative SMART therapy (50 Gy in 5 fractions, BED10=100 Gy)
03
Endpoints
Primary: 90-day grade 3 or higher toxicity, hypothesis <16%
Secondary: 2-year survival, distant recurrence free survival, quality of life
04
Results
• 0% grade 3+ toxicity definitively related to SMART therapy
• 8.8% grade 3+ toxicity possibly related to SMART therapy
• One-year survival 93%
05
Conclusions
Primary objective was met, signaling further prospective evaluation of ablative SMART therapy.
Primary Endpoint was met!

Tough-to-treat

Goal: Extend Survival

Pancreas


Conventional RT

LAP 07
Standard RT dose

15 months median survival for non-ablative RT + chemo vs ~16 month with chemo alone


MRIdian SMART

SMART pancreas
Ablative dose

Low toxicity endpoint met, early OS signal encouraging

Previous retrospective series show up to 26 months OS


Next up for

MRIdian SMART

LAP-ABLATE

To prove MRIdian SMART extends survival

Lung


Conventional RT

HILUS

15% grade 5 & 34% grade 3 after SBRT to central & ultra-central lung


MRIdian SMART

AUMC

8% grade 3 & 0% grade 5 after MRIdian SMART to central & ultra-central lung (retrospective)


Next up for

MRIdian SMART

LUNG STAAR

To prospectively prove the safety of MRIdian SMART to treat central & ultra-central lung

Clinical Trial Results

ASTRO 2022
Phase III: MIRAGE prostate (common cancer)

01
Study design
Phase III, randomized, single-institution
02
Treatment method
CBCT-guided vs MR-guided SBRT
03
Endpoints
Primary: 90-day grade 2 or higher GU and GI toxicity
Secondary: biochemical control (PSA control), OS, QOL
04
Results
• 60% reduced odds of grade 2+ GU toxicity (multi-variable analysis)
• Elimination of grade 2+ GI toxicity
05
Conclusions
MRI-guidance leads to a significant reduction in acute physician-scored GU & GI toxicity

More Common Cancers

Goal: Enhance Quality of Life

Prostate

Conventional RT

Mostly long-course treatment (28-45 fx)

Standard dose SBRT (36.25 Gy) shows similar toxicity to long-course RT

MRIdian SMART

MIRAGE High-dose SBRT

60% reduced chance of GU toxicity with MRgRT

No excess toxicity despite higher dose (40 Gy)

Next up for

MRIdian SMART

FORT & SHORTER

To move intact prostate SBRT to 2 fx and reduce the post-op treatment schedule without increasing toxicity

Breast

Conventional RT

Long-course treatment limits access to care

Shortened courses (APBI) carry the risk of poor cosmesis

MRIdian SMART

WashU, phase 1/2

Single fraction treatment with excellent cosmesis

Next up for

MRIdian SMART

BreaStBRT

Compare 5 fx vs 1 fx to demonstrate safety and improve quality of life & access to care