LEGACY Study
The LEGACY study is a robust multicenter study confirming TheraSphere as a neoadjuvant or standalone therapy in treating HCC.
Study Objective
To assess local tumor control and duration of response following treatment with Y-90 glass microspheres in patients with unresectable solitary HCC lesions.
Key Study Results
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Overall Survival(Treated population)93% overall survival rate in patients with transplant or resection following TheraSphere at 3 years. |
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Tumor Response(Best Response in evaluable population, localized mRECIST) |
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Study Design:
Multi-center, single-arm, retrospective study conducted at 3 U.S. sites.* Consecutive patients meeting the eligibility criteria were treated with TheraSphere Y-90 Glass Microspheres at each site between January 2014 and December 2017.
First and Only:
- Used highly clinically relevant criteria for localized tumor control (mRECIST)
- Reported a median dose to perfused liver volume of 410 Gy
- Demonstrated 100% of patients achieved CR or PR (localized mRECIST)
Key Eligibility Criteria:
Unresectable solitary lesions (≤ 8 cm); Selective, lobar, or mixed administration of Y-90 glass microspheres (TheraSphere); Treatment purpose (neoadjuvant to transplantation or resection or stand-alone treatment); Child-Pugh score A; BCLC A or BCLC C (ECOG 1); No prior liver transplantation, resection, locoregional treatment or systemic therapy; No portal vein thrombosis or extrahepatic disease.
Primary Study Endpoints Were MetDetermined by Blinded Independent Central Review (BICR) |
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| Safety: Majority of adverse events were mild and resolved without medical intervention. |
LEGACY STUDY CONCLUSION:
LEGACY is the first multicenter study to report a high median perfused volume absorbed dose of 410 Gy with TheraSphere, which resulted in an 88% best response, excellent and durable tumor control and high overall survival rate in patients with early and advanced HCC.
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The LEGACY Study Showcase
*University of Washington, Seattle, WA; Northwestern University, Chicago, IL; Mount Sinai Health System, New York, NY
1. Complete Response (CR) and Partial Response (PR) within the treatment area according to localized mRECIST
2. Duration of Response (DoR) According to localized mRECIST
3. Median follow-up was 29.9 months [95% CI: 24.7, 34.6]
PI-869706-AA