3 HCC patients

For your patients with unresectable hepatocellular carcinoma Personalised and versatile TheraSphereTM Y90 Therapy

EMBRACE THE POWER OF HOPE1,2

Preserve liver function while achieving tumour response3

Patient talking with doctor

TheraSphereTM Y90 Therapy has been shown to extend survival and provide predictable outcomes for patients with HCC. What is more, these benefits are obtainable without compromising on liver function.

Preserve liver function

➣ Throughout the study follow-up period, liver function maintained in patients with solitary unresectable HCC following TheraSphereTM Y90 Therapy4

Pivotal LEGACY trial (Salem et al. 2020)4

Pivotal LEGACY trial - Liver function
Pivotal LEGACY trial (Salem et al. 2020)-Summary

LEGACY (Salem et al. 2020)

• Multicentre
• Single-arm
• Retrospective

Patients with solitary unresectable HCC
• Tumour size <8 cm
• Child-Pugh A
• ECOG 0-1

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Achieve significant survival benefits

Patients with solitary unresectable HCC

➣ 93% Overall Survival rate at 3 years in patients with transplant or resection following TheraSphereTM Y90 Therapy3

Pivotal LEGACY trial (Salem et al. 2021)3

Overall survival in treated population

Pivotal LEGACY trial-Overall survival
  • 93% of patients alive following liver transplant or resection
    (95% CI: 74.2–98.2)
  • 86.6% of all patients alive following TheraSphereTM Y90 Therapy
    (95% CI: 78.2–92.0)
Pivotal LEGACY trial-Summary

LEGACY trial (Salem et al. 2021)

• Multicentre
• Single-arm
• Retrospective

Patients with solitary unresectable HCC
• Tumour size <8 cm
• Child-Pugh A
• 60% BCLC A, 40% BCLC C
• ECOG 0-1

Access the full LEGACY trial

Patients with unresectable locally advanced HCC 

➣ 26.6 months mOS demonstrated in patients following TheraSphereY90 Therapy with personalised multi-compartment dosimetry2

DOSISPHERE-01 Level 1 evidence study2

Overall survival in the intention-to-treat population

DOSISPHERE-01 Level 1 evidence study - Overall survival
  • 26.6 months median OS with personalised dosimetry
    (95% CI: 11.7–not reached)
  • 10.7 months median OS in the standard dosimetry group
    (95% CI: 6.0–16.8)

    HR: 0.421 (95% CI: 0.215–0.826, P=0.0096)
    23 months median OS for PVT patients in personalised arm vs 9.5 months in standard arm
    16-month survival improvement
DOSISPHERE-01 Level 1 evidence study - Summary

DOSISPHERE-01 trial (Garin et al. 2021)

• Phase II trial
• Randomised
• Multicentre (France)
• Open-label

Patients with unresectable locally advanced HCC
• ≥1 tumour ≥7 cm
• 90% BCLC C

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Deliver consistent and predictable clinical outcomes

Patients at any stage of HCC

➣ High tumour response rate demonstrated in multiple studies in patients treated with TheraSphere Y90 Therapy1,3,5,6

Evidence from multiple studies1,3,5,6

Level 1 randomised trial

Dospisphere-01 Level I randomised trial

A global real-world retrospective study

Dosisphere-01 A global real-world retrospective study

Multi-centre, single-arm, retrospective study

Dosisphere-01 Multi-centre, single-arm, retrospective study

Prospective, single centre, single-arm study

Dosisphere-01 Prospective, single centre, single-arm study

Reduce the incidence of complications

Patients with or without portal vein thrombosis (PVT)

Global real-world TARGET study5

Global real-world TARGET study
Learn more about the TARGET trial

Did you know?

TheraSphere Y90 Therapy does not increase the risk for hepatic failure or encephalopathy in patients with branch or no PVT compared with main PVT7

References

1.Gabr A, al. Liver Transplantation Following Yttrium‐90 Radioembolization: 15‐year Experience in 207‐Patient Cohort. Hepatology 2021;73(3):998-1010.

2.DOSISPHERE-01: Garin E, et al. Personalised 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 Jan;6(1):17-29.

3.LEGACY: Salem R, et al. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable HCC: The LEGACY Study. Hepatology. 2021; 74(5): 2342–2352.

4.Salem R, at al. 992P Yttrium-90 glass microspheres in the treatment of early and advanced hepatocellular carcinoma: The LEGACY study. 2020; Annals of Oncology 31:S692-S6

5.TARGET: Lam 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;49(10):3340-3352.

6.RASER: Kim E, et al. Radiation segmentectomy for curative intent of unresectable very early to early stage hepatocellular carcinoma (RASER): a single-centre, single-arm study. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):843-850.

7.Kulik LM, et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology. 2008 Jan;47(1):71-81.

Abbreviations

BCLC, Barcelona Clinic Liver Cancer; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma; HR, hazard ratio; mRECIST, modified Response Evaluation Criteria in Solid Tumours; OS, overall survival; PVT, portal vein thrombosis; Y90, yttrium-90.

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TheraSphereTM Y90 

Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.

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.

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