Recently, Merit Medical Systems (MMSI) received approval from the US Food and Drug Administration (FDA) for the phase III clinical trial protocol to treat primary liver cancer with QuadraSphere microsphere for delivery of doxorubicin.
The approval is significant since the late-stage study in the US will be the first to compare drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. At present, according to Merit Medical, there is no FDA-approved embolic for the treatment of liver cancer in the US.
QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations. While QuadraSphere has a long way to go before receiving the US approval, a similar product, HepaSphere is marketed in Europe since 2007 for embolization of HCC and hepatic metastases.
The phase III study is aimed at investigating HepaSphere/QuadraSphere microspheres for delivery of doxorubicin to treat HCC. While survival is the primary end-point of the study, secondary end-points include tumor response by mRECIST criteria, safety, resource utilization and adverse events. Approximately 500 patients are expected to be enrolled for the study at clinical sites across the US, Europe and South America.
Merit Medical had included microsphere products to its line of tumor treatment options with the acquisition of BioSphere Medical which was completed in September 2010. Through this acquisition, the company gained access to BioSphere’s embolotherapy technology platform. This technology finds applications in treating uterine fibroids and primary liver cancer, representing a global market potential of $650 million and $380 million, respectively.
Viewing the untapped potential in the liver cancer market, it is expected that successful commercialization of microspheres in the US will be beneficial to Merit Medical over the long term. While liver cancer is the third leading cause of cancer deaths globally, its occurrence has increased with rise in hepatitis C infections, alcohol consumption and obesity.
Although liver transplantation or tumor resection is considered a curative treatment; only 25% of liver cancers are diagnosed when they can be treated surgically. It has been witnessed that in cases where surgery is not a viable option, TACE has shown promising results.
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