Updated Results Reported for ThermoDox in Primary Liver Cancer
Doxorubicin plus radio frequency ablation improves overall survival (January 27)
Updated overall survival data have been reported from a post hoc analysis of results from the phase III HEAT study of ThermoDox, a heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation (RFA), in patients with primary liver cancer.
According to the product’s developer (Celsion Corporation), the new data support the continued clinical development of the treatment in a prospective pivotal phase III study, subject to regulatory review and agreement.
This new analysis followed the announcement on January 31, 2013, that the HEAT study did not meet its primary endpoint, progression-free survival (PFS). As provided for in the study’s special protocol assessment (SPA) agreement with the FDA, Celsion continues to follow patients for overall survival, the trial’s secondary endpoint.
The new data suggest that ThermoDox may significantly improve overall survival (OS), compared with control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single hepatocellular carcinoma lesions (64.4% of the HEAT population) from both size cohorts (3 to 5 cm and 5 to 7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT study). Updated OS data from this subgroup of patients are summarized below:
- In the patient subgroup treated in the ThermoDox arm, whose RFA procedure lasted longer than 45 minutes (285 patients, or 63% of single-lesion patients), clinical results indicated a 55% improvement in OS (hazard ratio [HR], 0.64; P = 0.0495). Median overall survival for this subgroup has not yet been reached.
- In contrast, the patient subgroup treated with ThermoDox whose RFA procedure lasted less than 45 minutes (167 patients, 37% of single-lesion patients) indicated an HR of 1.12 and a P value of 0.66. Median overall survival for this subgroup has not yet been reached.
Source: Celsion Corporation; January 27, 2014.