HCC: resminostat boosts overall survival

Detailed results with the oral histone deacetylase blocker + sorafenib from the Phase II study, which commenced last December, reported no improvement in time to disease progression in June, and suggested benefits in a subgroup with high biomarker expression in October, were presented at the 2017 Gastrointestinal Cancers Symposium in San Francisco.

As reported earlier, subgroup analysis of the Phase II study revealed that addition of resminostat to the standard of care sorafenib resulted in a prolonged time until disease progression and a substantial benefit in median overall survival in patients with a normal to high thrombocyte count at study entry, explains Frank Hermann, M.D., Chief Development Officer of 4SC. At median, patients in this subgroup treated with resminostat and sorafenib survived for 13.7 months compared to 5.1 months in patients treated with sorafenib alone. 

These are the first clinical data obtained in a randomised, controlled Phase II trial conducted in patients with advanced HCC indicating that platelet count might serve as a potentially relevant selection criterion. These interesting results are worthy of further exploration in a pivotal Phase III study, said Prof. Edoardo Giannini, from the University of Genoa, who is member of the global HCC advisory board meeting of 4SC. Although baseline platelet count is not yet an established selection criterion for patients in oncology and particularly in HCC, we have received a lot of positive feedback from leading experts in the HCC field. added 4SC CEO Jason Loveridge, „particularly since the patients where we see most benefit, are those with more advanced disease and with poorer prognosis.