Sirtex Medical Receives FDA Approval to Conduct DOORwaY90 Study of SIR-Spheres in Unresectable HCC

March 22, 2021––Sirtex Medical announced full FDA approval of the DOORwaY90 study, which is evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using the company’s SIR-Spheres yttrium-90 (Y-90) resin microspheres in patients with unresectable hepatocellular carcinoma (HCC).

The company stated that DOORwaY90, which stands for “Duration of Objective Response with Arterial Y-90,” is a prospective multicenter study to utilize and delineate personalized dosimetry treatment planning and define actionable posttreatment dosimetric verification for endpoint assessment. The study will assess the duration of response and objective response rate of SIR-Spheres.

According to Sirtex, the 15-center, 100-patient, United States–based, open-label, single-arm DOORwaY90 study will be run in accordance with Good Clinical Practice. The study population consists of patients with Barcelona Clinic Liver Cancer stage A, B1, and B2 who are not eligible for resection or ablation at the time of study entry. For each patient, an eligibility review committee will review diagnostic imaging and confirm final eligibility and treatment planning prior to treatment. Enrollment is expected to begin in early Q2 2021.

The DOORwaY90 study is being led by Coprincipal Investigators Cheenu Kappadath, PhD, and Armeen Mahvash, MD, who are with University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Kappadath is Associate Professor in the Department of Imaging Physics. Dr. Mahvash is Professor in the Department of Interventional Radiology, Division of Diagnostic Imaging.

“We are honored to participate in this important study that could greatly impact the treatment of HCC patients in the United States,” commented Dr. Mahvash in the company’s press release. “We look forward to working closely with Sirtex in executing and reporting the findings of DOORwaY90.”

Sirtex noted that outside the United States, SIR-Spheres are indicated for the treatment of patients with advanced nonoperable liver cancer, including HCC. Kevin Smith, Chief Executive Officer at Sirtex, stated, “Our therapy is used for treatment in HCC in more than 50 countries, with years of safety and efficacy. The DOORwaY90 study has the potential to expand the FDA-approved indication for use of SIR-Spheres in the United States, which would mark an incredible achievement in patient care.”

Sirtex noted that SIRT has the potential to deliver a lethal dose of radiation to hepatic tumors while sparing surrounding healthy liver tissue. In countries outside the United States, SIRT has been successfully used to bridge patients to transplantation or downstage HCC to within transplantation criteria or resection.

SIR-Spheres Y-90 resin microspheres are approved for use in Argentina, Australia, Brazil, the European Union with CE Mark approval, Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In the United States, they have a premarket approval from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy of floxuridine.