Phase II success for resminostat (4SC) in Liver Cancer

4SC AG announced the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced Liver Cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER study enrolled patients with advanced Liver Cancer (Hepatocellular Carcinoma, HCC) who had shown proven radiological tumor progression under first-line therapy with the cancer drug Nexavar (sorafenib). The study investigated safety and efficacy of resminostat as a monotherapy and in combination with sorafenib in this patient group with currently no approved treatment option. Final median overall survival (OS) of 8.0 months was determined in the resminostat/sorafenib combination 'intend-to-treat' (ITT) population (n=26), i.e. all study patients who were treated with the combination of 600 mg resminostat total daily dose (TDD) and 400 mg sorafenib TDD. In the resminostat monotherapy group (ITT population, n=19), the final median OS value has been determined as 4.1 months. All presented data are subject to review upon database lock. In both study arms, resminostat has proven to be safe and well tolerated. Notably, the overall health condition of the patients enrolled in the SHELTER study was particularly severe (measured by the clinical parameters ECOG status, BCLC stage and Child-Pugh class) compared to other clinical studies with alternative investigational drugs in second-line HCC patient populations.