Boston Scientific has reported positive data from the Phase III EPOCH clinical trial of its TheraSphere Y-90 Glass Microspheres (TheraSphere treatment) in patients suffering from metastatic colorectal cancer (mCRC) of the liver.
The trial met the primary endpoints of progression-free survival (PFS) and hepatic progression-free survival (hPFS).
TheraSphere treatment is a selective internal radiation therapy (SIRT) that involves specific delivery of microscopic glass beads carrying radioactive yttrium (Y-90) to target tumours through a catheter.
It is indicated for patients with hepatic neoplasia/malignancies, including mCRC of the liver, in Canada, Europe and Asian regions.
In the EPOCH trial, the treatment was given as a second-line therapy along with the standard of care systemic chemotherapy (SOC) for patients whose disease progressed during or following first-line chemotherapy.
Boston Scientific peripheral interventions interventional oncology president Peter Pattison said: “EPOCH is the first positive Phase III SIRT trial in any disease setting and the data is expected to support our regulatory submission to the US FDA, with the hope that more patients with liver dominant mCRC will gain access to TheraSphere as a treatment option in the future.”
The global, prospective, pivotal EPOCH trial involved a total of 428 mCRC patients and compared the therapeutic benefit of SOC when given in combination with or separately from TheraSphere treatment.
Boston Scientific noted that the addition of TheraSphere treatment led to a meaningful increase in PFS and hPFS.
Participants on TheraSphere treatment with second-line chemotherapy had 31% less chance of disease progression or death and 41% less chance of hepatic disease progression or death compared to chemotherapy alone.
EPOCH trial co-principal investigator Mary Mulcahy said: “In the second line of therapy for mCRC, with disease isolated to the liver, the addition of TheraSphere with chemotherapy resulted in a significant delay in overall tumour progression.
“Additionally, chemotherapy-related adverse events were comparable between the trial arms.”
In March, the US Food and Drug Administration approved the TheraSphere Y-90 Glass Microspheres technology to treat patients with hepatocellular carcinoma (HCC).
The agency also granted breakthrough device status for treating glioblastoma.