TheraSphere™ Y-90 Glass Microspheres

PROACTIF study HCC data

HCC data overview

PROACTIF: A prospective, real-world, Y-90 study with TheraSphere for the treatment of liver malignancies: interim analysis of 873 hepatocellular carcinoma (HCC) patients.

PROACTIF HCC data sheet

TheraSphere prospective, real-world Y-90 study interim analysis

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See full abstract publication*

*Data below and in data sheet has been refined to reflect an updated dataset for oral presentation at 2024 SIR Annual Scientific Meeting.

TheraSphere Y-90 glass microspheres demonstrated high overall survival in intermediate and advanced HCC patients in PROACTIF, the largest, prospective, real-world, Y-90 study of primary liver cancer in 1,000+ patients.

Interim HCC analysis*

870+ patients across 30+ sites demonstrated positive results and builds on previously published landmark trials.

High overall survival for intermediate & advanced stage HCC patients

Median overall survival of 21.1 months, BCLC B at 29.6 months, BCLC C at 17.7 months.

Subgroup analysis demonstrated prolonged survival in patients who received selective treatment, were ALBI Grade 1, or had Unilobar disease*

Proactiv subgroup analysis demonstrating prolonged survival in patients who received selective treatment.

Data from 30+ sites used contemporary techniques and dosing*

70% multi-compartment dosimetry; 49% selective administration.

Real-word treatment scenarios span curative to palliative intent

Graph showing percentage of patients in the following areas: downstaging or bridging to surgery-15.1, obtaining complete response-24.9, disease control-47.4, other or unknown-7.8 and missing-4.8.

Majority of patients were intermediate / advanced stage with index lesions > 5cm*

Patient demographics and disease characteristics

Conclusion

Interim analysis of 873 HCC patients across 32 sites demonstrated high overall survival in intermediate and advanced HCC patients. Data builds on evidence from previously published landmark trials such as DOSISPHERE-01 and TARGET.

Proactiv study comparison to Dosisphere-01 study and Target study across study design, BCLC %, ECOG %, CP A/B, PVT, unilobar/bilobar disease and median OS.

*Interim data presented at SIR 2024. Data collection as of 12/30/2023. Final results are expected in 2025

** Based on mITT population.

Garin E, Tselikas L, Guiu B et al. Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021, 6: 17-29.
Lam, M., Garin, E., Maccauro, M. et al. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging (2022). https://doi.org/10.1007/s00259-022-05774-0.
Garin E, Tselikas L, Guiu B, et al. Long-Term Overall Survival After Selective Internal Radiation Therapy for Locally Advanced Hepatocellular Carcinomas: Updated Analysis of DOSISPHERE-01 Trial. J Nucl Med. 2024;65(2):264-269. Published 2024 Feb 1. doi:10.2967/jnumed.123.266211

Garin E, Bailly C, Letang A et al. Abstract No. 257 • Featured Abstract The PROACTIF French Registry Study of Y-90 Glass Microspheres for the Treatment of Liver Malignancies: Interim Analysis of 670 Hepatocellular Carcinoma (HCC) Patients. J Vasc Interv Radiol. 2024 Mar 35(3):S113 doi: https://doi.org/10.1016/j.jvir.2023.12.295 (updated dataset for oral presentation at SIR March 2024)

TheraSphere indications, safety, and warnings

TheraSphere is a registered trademark of Theragenics Corporation used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.