OMS ElectroChemotherapy: Interim Phase III data

Delayed interim data from 189 evaluable patients with SCCHN in the open-label, international Phase III HNBE-01 and HNBE-02 trials showed that OMS ElectroChemotherapy met the primary endpoint of preserving quality of life as measured by PSSHN scores vs. surgery. Specifically, PSSHN scores in patients receiving OMS ElectroChemotherapy were reduced to 249 points at 8 months from 257 points at baseline (p=0.59) vs. a significant reduction to 248 points from 269 points for patients receiving surgery (p=0.036). There were no significant differences between OMS ElectroChemotherapy and surgery in median time to death (231 vs. 209 days, p=0.55) or 8-month local tumor control rates (90% vs. 92%). The incidence of the most common adverse events - pain, nausea and local edema - was equivalent between treatment groups. The trials enrolled 214 patients with locally recurrent or second primary tumors, anterior and posterior to the tonsillar pillar, respectively, and amenable to surgical resection. Patients randomized to surgery also received standard of care (SOC) radiation. Data were presented at the International Conference on Head and Neck Cancer in Toronto. ...