On September 27, 2014 Ipsen reported the presentation at the ESMO (Free ESMO Whitepaper) 2014 Congress (26-30 September in Madrid) of the preliminary results of the phase II proof-of-concept clinical trial with tasquinimod in monotherapy, evaluating the compound in four advanced tumor types (Press release Ipsen, SEP 27, 2014, View Source [SID:1234500764]).

The main objective of the study was to determine the clinical activity of tasquinimod in advanced hepatocellular (HCC), ovarian (OC), renal cell (RCC) and gastric (GC) carcinomas in patients who had progressed after standard anti-tumor therapies. Primary endpoint was the PFS rate at a predefined time for each cohort. Secondary objectives included PFS, response rate, OS, safety, pharmacokinetics and biomarkers.

The data did not support further development of tasquinimod in monotherapy in heavily pretreated patients with advanced OC, RCC and GC. Pharmacokinetic and biomarkers analyses are ongoing. Preliminary results from the futility analysis reported sufficient clinical activity to complete the recruitment of the HCC cohort for which results are expected in 2015.
The safety profile was consistent with the known safety profile of tasquinimod in previous studies.

Data from the HCC cohort was presented (Poster p-171)1 at the International Liver Cancer Association 8th Annual Conference (5–7 September 2014, Kyoto, Japan).