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No established regimens exist for the treatment of patients with advanced hepatocellular carcinoma after failure of first-line treatment with the multikinase inhibitor sorafenib. Outcomes in the setting of sorafenib resistance or intolerance are poor, with a median expected overall survival for the placebo arms of second-line trials in the range of 7 to 8 months.

In recent years, knowledge of hepatocellular carcinoma (HCC)-specific tumor-associated antigens and the development of immune checkpoint blockade therapy has offered a positive outlook for patients with HCC.

Data from the pivotal KEYNOTE-001 trial showing pembrolizumab's efficacy in pretreated non-small cell lung cancer were presented just days before the FDA is scheduled to make its approval decision on the PD-1 inhibitor in this setting (October 2, 2015).

The Inaugural International Cancer Immunotherapy Conference commenced September 16, 2015, in New York City, and one presentation detailed Biothera's new biomarker strategy in patient selection for the company's investigational cancer immunotherapy, Imprime PGG.