The Instylla HES Hypervascular Tumor Study
The first and only FDA-approved liquid embolic for hypervascular tumor embolization supported by a prospective, randomized clinical trial
The Instylla HES Hypervascular Tumor Study
The first and only FDA-approved liquid embolic for hypervascular tumor embolization supported by a prospective, randomized clinical trial
About the Instylla HES Hypervascular Tumor Study
The Instylla HES Hypervascular Tumor study is a prospective, randomized, multi-center, subject and evaluator blinded pivotal trial evaluating the Instylla HES against Standard of Care, Transcatheter Arterial Embolization (TAE)/ Transcatheter Arterial Chemoembolization (cTACE) procedures. The study focuses on the treatment of hypervascular tumors, with clinical and imaging follow-ups at 30 and 90 days and clinical follow-up at 180 days.
Key Study Results
Technical Success†
Compared to 77.3% success with Standard of Care (SoC)
†As determined by an independent core lab.
FREEDOM FROM MAEs
As adjudicated by the CEC, NO adverse events designated as device-related only*
*Clinical Events Committee (CEC)
Patient Eligibility Criteria**
- Confirmed hypervascular tumor on CT and/or MRI
- TAE/TACE medically indicated
- ECOG PS 0–2 (PS 0-1 for metastatic disease)
- At least one target vessel ≤ 5 mm
- Expected life expectancy 6 months post-embolization
- Tumor lesion < 8 cm in diameter
The First and Only Liquid Embolic
- FDA-approved for hypervascular tumor embolization
- Proven in a randomized trial vs. Standard of Care (TAE or cTACE)
- With no clinically significant non-target embolization (NTE) observed in a pivotal study
Procedural Details
| Patient Characteristics | Hydrogel Embolic System (HES) N=102 | Standard of Care TAE/cTACE N=48 |
|---|---|---|
| Age in Years Mean ± SD (N) | 65.6 ± 12.37 (102) | 65.1 ± 14.09 (48) |
| No Previous Chemotherapy | 63.7% (65/102) | 79.2% (38/48) |
| No Prior Radiation | 83.3% (85/102) | 77.1% (37/48) |
| No Other Targeted Therapies | 74.5% (76/102) | 68.8% (33/48) |
| Metric | HES N=102 | SOC N=48 |
|---|---|---|
| Mean (± SD) Number of Lesions Treated | 1.2 ± 0.52 | 1.2 ± 0.49 |
| Mean (± SD) Vessel Size Treated (mm) | 2.0 ± 0.80 | 2.1 ± 0.84 |
| Median Embolization Time (min) | 5.0 | 5.0 |
| Mean (± SD) Cumulative Fluoroscopy Time (min) | 25.2 ± 17.72 | 23.3 ± 15.42 |
| Mean (± SD) Volume Delivered Per Vessel (mL) | 5.5 ± 7.0 | 7.4 ± 8.25 |
Additional Observations
- Disease Control Rate†† across non-hepatic, non-HCC hepatic, and primary liver lesions was >90% at 90 days.
- The HES arm exhibited a numerically lower incidence of additional embolization procedures beyond the 90-day follow-up (8.8% vs. 14.6% in Standard of Care)
- Embolization with HES as a single agent was performed in > 96 % of cases; SOC treatment arm incorporated multiple embolic agents in 39.6% of cases
Conclusions
SINGLE AGENT EMBOLIZATION
>96% IN HES ARM VS. >60% IN SOC ARM
**For a full list of eligibility criteria visit https://clinicaltrials.gov/study/NCT04523350
††Disease Control Rate includes Partial Responses, Complete Response, and Stable Disease.