A new imageable glass yttrium-90 (Y-90) radioembolization therapy has shown early safety and effectiveness in a first-in-human study for treating patients with unresectable hepatocellular carcinoma (HCC).
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HCC, the most common type of liver cancer, is now the fifth most common cause of cancer worldwide, according to the National Library of Medicine (NLM). The NLM also states that it is the second-leading cause of cancer death (after lung cancer) in men, and more than 80% of new HCC cases are in developing countries, which have high burdens of hepatitis B infection.
The Featured Abstract “Multimodal Imageable Eye90 microspheres® Radioembolization for Hepatocellular Carcinoma—6-month Interim Safety and Efficacy and 3-month Liver Volume Results from a First in Human Trial” will be presented during Monday’s Scientific Session 15, Liver Locoregional 1, from 3–4:30 p.m. MT.
Eye90 is being developed by ABK Biomedical Inc., a medical device company that was co-founded by researchers at Dalhousie University in Halifax, Nova Scotia, Canada. Eye90 allows for direct visualization of the microspheres as they’re deposited into the tumor—rather than waiting for SPECT or PET imaging for confirmation of tumor targeting after the procedure as occurs with current Y-90 therapies.
“The fact that we can directly visualize Eye90 microspheres on CT is a significant benefit for patient care decisions, as adequate tumor targeting and coverage can be evaluated and confirmed on a readily available imaging modality,” said Robert Abraham, MD, an IR and professor in the department of diagnostic radiology at Dalhousie University and co-founder of ABK Biomedical.
Eye90 also uses a new administration system. “This advanced delivery system allows for consistent microsphere concentration during injection and offers flexibility in delivery with the ability to pause and reassess treatment using CT modalities or by allowing for injection of contrast media through the system to assess blood flow or to confirm catheter tip position as needed,” Dr. Abraham said. “It also provides the potential to monitor and adjust therapy when treating our patients.”
In the first clinical trial of Eye90 microspheres, six patients underwent treatment at Auckland Hospital in New Zealand by the principal investigator, Prof. Andrew Holden, MD. At 90 and 180 days, three of the six patients saw complete response and one patient had stable disease. Two patients with partial response at 90 days were subsequently treated with transarterial chemoembolization for residual tumor. All reported adverse events, such as pain and fatigue, would be expected with Y-90 therapy as well. There were no serious, treatment-related adverse events and no evidence of radioembolization-induced liver disease or radiation-induced lung injury.
“This pilot trial has provided preliminary confirmation of safety and effectiveness,” Dr. Abraham said. “We have since commenced a multicenter, prospective, pivotal IDE trial in the U.S. named Route90 to evaluate safety and efficacy in a larger number of patients, and we will be exploring additional benefits of the technology such as the potential to use Eye90 radiopacity to perform CT based dosimetry.”
Eye90 microspheres was recently granted U.S. Food and Drug Administration (FDA) breakthrough device designation. “The FDA breakthrough designation highlights the significant potential for this technology, and we are all looking forward to the results of this pivotal trial,” Dr. Abraham said.
