HEAT Study: ThermoDox increased OS in patients with HCC

Updated results from the HEAT Study indicated an increased overall survival rate among patients with primary liver cancer when treated with ThermoDox combined with radiofrequency ablation, according to a press release.

As of January 15, 285 patients with HCC (41% of study patients) treated with ThermoDox (liposomal encapsulated doxorubicin, Celsion) in combination with optimized radiofrequency ablation (RFA) demonstrated a 59% improvement in overall survival (OS) (HR = 0.628 ; 95% CI, 0.420-0.939) compared with patients treated with optimized RFA alone, according to a press release from Celsion.

Previous results announced in an August 2014 press release stated that there was a 57% improvement in OS (HR = 0.639 ; 95% CI, 0.419-0.974) among patients undergoing treatment with ThermoDox and RFA compared with patients treated with RFA alone. These results were an increase from previous results released in a March 2014 press release, when a 50% improvement in OS (HR = 0.666 ; 95% CI, 0.434-1.022) was observed.

“The consistency of the data from the HEAT Study over the past 2 years is quite compelling, demonstrating the significant potential for ThermoDox in combination with an optimized RFA regimen to markedly improve overall survival in primary liver cancer patients,” Riccardo Lencioni, MD, FSIR, EBIR, professor and director of the diagnostic imaging and intervention at the Pisa University School of Medicine in Italy, said in the press release. “These findings provide a strong rationale for the ongoing OPTIMA Study and may also underscore the interest of clinical investigators to evaluate the potential of ThermoDox plus optimized RFA for curative intent among intermediate stage HCC patients.”

Michael H. Tardugno, president and chief executive officer of Celsion, added: “The lessons learned from the HEAT study together with prospective supportive preclinical study results formed the basis for our global phase 3 OPTIMA Study evaluating ThermoDox in combination with a standardized RFA protocol in primary liver cancer, and we look forward to sharing this latest data update with our investigators worldwide as we continue to advance this program.”

The phase 3 OPTIMA Study was approved in Europe in November 2014 and is expected to enroll up to 550 patients from up to 100 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA.