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ARTICLE | Clinical News

SIR-Spheres miss Phase III OS endpoint

May 19, 2017 12:16 AM UTC

Sirtex Medical Ltd. (ASX:SRX) said SIR-Spheres missed the primary endpoint of improving median overall survival (OS) compared to Nexavar sorafenib in the Phase III SARAH trial to treat locally advanced or inoperable hepatocellular carcinoma (HCC) (8 vs. 9.9 months, p=0.179). SIR-Spheres also missed the secondary endpoint of improving median progression-free survival (PFS) vs. Nexavar (4.1 vs. 3.7 months, p=0.765).

SIR-Spheres did significantly improve overall response rate (ORR) (19% vs. 11.6%, p=0.042) and quality of life (QOL) as measured by the Global Health Status scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (p=0.005) vs. Nexavar. Additionally, a significantly smaller proportion of patients who received SIR-Spheres experienced ≥1 treatment-related adverse event vs. Nexavar (76.5% vs. 94%, p<0.001). The open-label, French trial enrolled 459 patients who did not respond to other treatments or had failed 2 rounds of transarterial chemoembolization. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam...

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