Two Phase III studies of OMS ElectroChemotherapy (OncoSec Medical) show QoL benefits

Data from an interim analysis of two Phase III trials, HNBE-01 and HNBE-02, using OMS ElectroChemotherapy, from OncoSec Medical, to treat locally recurrent and second primary squamous cell carcinoma of the head and neck enhances patients quality of life.

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, where local control is defined as destruction of the treated tumor without evidence of reappearance of the tumor at the treatment site. The data show OMS ElectroChemotherapy achieved the primary endpoint of preserving quality of life compared to surgery, and appears to be safe and comparable to surgery in achieving control in locally recurrent or second primary SCCHN. However there were no statistically significant differences between time to death or local control rate at eight months.

These studies were initiated in 2004 and subsequently closed in 2007, and were conducted at 22 sites in the United States, Canada, Eastern and Western Europe. Of the 214 enrolled subjects, 130 were randomized into HNBE-01 and 84 into HNBE-02. The studies was terminated at the interim point following an independent data monitoring committee review; however, all treated patients were followed for up to two years to evaluate safety and efficacy. The interim analysis of long-term follow-up data at up to two years indicates there were no safety issues relating to electrochemotherapy, as reflected by the statistically significant equivalence between the groups in time to death.