Post-hoc analysis of Phase III study with ThermoDox (Celsion Corp) indicates benefits for Liver Cancer

Post-hoc analysis of data from the Phase III HEAT study of ThermoDox (heat activated liposomal doxorubicin), from Celsion Corporation, in patients with Liver Cancer, suggests that heating cycles can be optimized to markedly improve radiofrequency ablation (RFA) results. Though ThermoDox failed to meet the primary endpoint in the Phase III HEAT trial, the new data indicates that it may provide potential for clinically relevant improved progression free survival (PFS) and Overall Survival (OS) outcomes.

In the ThermoDox subgroup whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients) OS improved by 66% when compared to the control arm of RFA treatment only. In the ThermoDox subgroup whose RFA procedure lasted longer than 90 minutes (23% of single lesion patients), OS almost doubled compared to the control. When combined, these two subgroups show clinical results that indicated a 53% improvement in OS, a Hazard Ratio of 0.65, and a Pvalue = 0.105.

The data was presented by Professor Riccardo Lencioni, Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Italy, at the 2013 European Conference on Interventional Oncology.