Sirtex reports 100% tumor control in Y-90 HCC study

Sirtex Medical has reported 12-month results from the DOORwaY90 study of SIR-Spheres Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma. The data were presented at the Society of Interventional Radiology annual meeting in Toronto.

DOORwaY90 met its prespecified co-primary endpoints, with a 90% complete response rate and a 99% best overall response rate by blinded independent central review, according to the company. All evaluable patients responded to treatment, resulting in 100% local tumor control.

Responses were durable in the 12-month analysis. Sirtex said 75% of responses lasted beyond 6 months, with a median duration of response of 295 days.

More than 95% of patients maintained stable liver function at 12 months, according to the company. Sirtex also reported that the results were achieved using partition dosimetry.

The company described DOORwaY90 as the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy using partition dosimetry for unresectable HCC. Trial design details published in BMC Gastroenterologydescribe DOORwaY90 as a prospective, multicenter, open-label, single-arm study evaluating Y-90 resin microspheres as first-line treatment for unresectable or unablatable HCC.

SIR-Spheres Y-90 resin microspheres are indicated in the U.S. for local tumor control of unresectable HCC in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status, according to Sirtex product information.