Patients with HCC displayed increased OS in latest update of ThermoDox study

Results from a recent study post-hoc analysis indicated an increased overall survival rate among patients with primary liver cancer when treated with encapsulated doxorubicin enhanced with lysolipid thermally sensitive liposomes in combination with radiofrequency ablation, according to a media release.

ThermoDox (Celsion), in combination with optimized radiofrequency ablation (RFA) demonstrated a 57% improvement in overall survival (OS) (HR=0.639; 95% CI, 0.419-0.974), an increase from previous results, compared to those treated with RFA alone, according to a media release from Celsion. Previous results announced in a different media release stated that as of March 30, a 50% improvement in OS (HR=0.666; 95% CI, 0.434-1.022) was observed among patients undergoing treatment with ThermoDox and RFA compared with patients treated with RFA alone.

The results of both analyses applied to patients with single hepatocellular carcinoma (HCC) lesions (64.4% of the HEAT study population) from both size cohorts of the HEAT study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (of 701 patients), according to the release.

"As the data from the HEAT study matures, it increasingly underscores the significant potential of ThermoDox plus optimized RFA 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, Italy, said in the release. “There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox in this indication."

“The post-hoc HEAT study data is striking in that it has consistently shown a marked OS benefit for ThermoDox plus optimized RFA vs. RFA alone in each of the quarterly data sweeps, with this fifth and final data set demonstrating that this survival benefit is statistically significant," Michael Tardugno, president and chief executive officer of Celsion, said in the release. "This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our phase 3 OPTIMA study in primary liver cancer, which is evaluating ThermoDox in combination with a standardized RFA protocol in primary liver cancer."