September 14, 2020
NASIR-HCC Study Evaluates Nivolumab Use Following Sirtex Medical’s SIRT to Treat Liver Cancer
September 14, 2020—Sirtex Medical announced that positive trial data from the NASIR-HCC study of hepatocellular carcinoma (HCC) treatment were reported by principal investigator Professor Bruno Sangro, MD, at the International Liver Cancer Association’s ILCA 2020 virtual conference held online September 11-13.
NASIR-HCC is evaluating the safety, tolerability, and preliminary antitumoral efficacy of selective internal radiation therapy (SIRT) using Sirtex’s targeted liver cancer therapy, SIR-Spheres yttrium-90 (Y-90) resin microspheres, followed by nivolumab (Bristol Myers Squibb), a targeted anti–PD-1 cancer therapy in 42 patients with HCC.
The multicenter phase 2 single-arm clinical trial was conducted at nine academic hospitals in Spain. Patients enrolled in NASIR-HCC had large single or multiple tumors including those with unilobar segmental or lobar portal vein thrombosis, preserved liver function, and no extrahepatic disease.
According to the company, the results showed:
- 12% of patients experienced a serious adverse event that was considered related to treatment.
- 2.3% of patients experienced treatment-related adverse events leading to permanent nivolumab discontinuation.
- No radioembolization-induced liver disease or treatment-related deaths were observed.
Additionally, SIR-Spheres Y-90 resin microspheres followed by nivolumab demonstrated a favorable safety profile with no signs of synergistic toxicity.
The overall response rate was observed in 40% of patients, including 12.5% who had a complete tumor response and 27.5% with partial tumor response. Future randomized controlled trials are needed to further explore and confirm the efficacy of SIRT treatment followed by nivolumab, advised Sirtex.
“It's an honor to present our findings to fellow professionals in the liver cancer community so we can advance oncological care for patients demonstrating safety, tolerability and early antitumoral efficacy of combination therapy with SIRT followed by nivolumab,” said Prof. Sangro, who is Director of the Liver Unit, and Professor of Internal Medicine at the Clinica Universidad de Navarra in Pamplona, Spain. “I express deep thanks to our multicenter team, Sirtex, BMS, and our other supporters for their efforts to complete this successful study.”