HEAT study: ThermoDox increases OS in HCC patients

Updated results from the HEAT study indicated an overall survival rate of over 50% among patients with primary liver cancer when treated with ThermoDox combined with radiofrequency ablation, according to a press release from Celsion Corporation.

As of July 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 58% OS (HR = 0.63; 95% CI, 0.43-0.93; P = .0198) compared with patients treated with optimized RFA alone, according to a press release. These results are similar to the last update of the study, which was released in February.

The latest results indicate that ThermoDox has the “potential to significantly improve OS compared to an RFA control in patients with [single HCC] lesions” that undergo treatment with optimized RFA treatment for at least 45 minutes, according to the release. Findings from this post-hoc analysis applies to 64.4% of the HEAT study population.

“These results from the HEAT study reinforce the potential for ThermoDox in combination with an optimized RFA regimen to serve as an effective treatment option that could significantly improve overall survival in primary liver cancer patients,” Nicholas Borys, senior vice president and chief medical officer of Celsion, said in the release. “The data from our study suggests a greater than 2-year median survival advantage for the ThermoDox plus optimized RFA group, a meaningful finding given that few treatments are effective in prolonging survival in HCC.”

Other 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 continuing strength of the HEAT Study data reinforces our confidence in ThermoDox as the first and only front line therapy for newly diagnosed HCC patients and further improves the risk profile of our phase 3 OPTIMA Study, currently enrolling patients in 12 countries globally,” Michael H. Tardugno, president and CEO of Celsion, said in the release. “Equally important is the maturing data and the remarkable clinical benefit seen in the Chinese patient cohort. This large 221 patient subgroup represents a country with over 50% of the world's incidence of HCC every year.”

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.

Disclosures: Borys and Tardugno report being employed by Celsion.