US-based prospective, multicenter study to evaluate SIRT in HCC

Sirtex Medical announced that the DOORwaY⁹⁰ Study, a trial evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma (HCC), has received full US FDA approval.

DOORwaY⁹⁰, which stands for "Duration of Objective Response with Arterial Y-90," is the first prospective, multicenter study to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment. The study will assess the duration of response (DoR) and objective response rate (ORR) of SIR-Spheres.

The DOORwaY⁹⁰ Study is being led by co-principal investigators Cheenu Kappadath, PhD, and Dr. Armeen Mahvash. "We are honored to participate in this important study that could greatly impact the treatment of HCC patients in the United States," noted Dr. Mahvash, Professor in the Department of Interventional Radiology Division of Diagnostic Imaging at the University of Texas MD Anderson Cancer Center. "We look forward to working closely with Sirtex in executing and reporting the findings of DOORwaY⁹⁰ ."

DOORwaY⁹⁰  is a 15-center, 100-patient, U.S.-based open label, single arm study run in accordance with Good Clinical Practice (cGCP). The study population consists of patients with Barcelona Clinic Liver Cancer (BCLC) 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.

Globally, SIR-Spheres are indicated for the treatment of patients with advanced non-operable liver cancer, including HCC. "Our therapy is used for treatment in HCC in more than 50 countries, with years of safety and efficacy," said Kevin Smith, Chief Executive Officer at Sirtex. "The DOORwaY⁹⁰ Study has the potential to expand the FDA-approved indication for use of SIR-Spheres in the U.S., which would mark an incredible achievement in patient care."