Sirtex Medical Limited (ASX:SRX) today announces the launch of a new Investigator Initiated Trial (IIT) in non-resectable advanced hepatocellular carcinoma (HCC), the most common type of primary liver cancer. The study, known as NASIR-HCC, is a multi-centre, open label, single-arm study of the safety and anti-tumour efficacy of Opdivo® (nivolumab, Bristol-Myers Squibb Company) after SIRSpheres microspheres for the treatment of patients with HCC that are candidates for loco-regional therapies. The primary endpoint is safety. Key secondary endpoints include Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), Time to Progression (TTP) and Progression-Free Survival (PFS). The study is expected to recruit 40 patients.
The principal investigator of the study is Professor Bruno Sangro, Director of the Liver Unit at Clinica Universidad de Navarra, Spain. Sirtex is a financial sponsor of the study.
The scientific hypothesis underpinning the rationale for the study combination is that by inducing tumour cell death, SIR-Spheres may have a synergistic effect with immune checkpoint inhibitors by priming the immune system via the radiation-induced release of tumour antigens prior to treatment with nivolumab, which additionally takes the handbrake off immune system recognition of cancer cells.
Mr Andrew McLean, Chief Executive Officer of Sirtex Medical said “The NASIR-HCC study forms part of our clinical strategy that seeks to add value to our core product through small, targeted IITs using our therapy in combination with drug-based treatments like checkpoint inhibitors, which are in clinical development for a range of different cancer types, including HCC. This is the second IIT looking at this unique combination, with a similar study ongoing in Singapore.”
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