REO 015 was a single-arm, open-label, dose-targeted Phase II trial of REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory, recurrent and/or metastatic squamous cell cancers of the oral cavity, larynx or pharynx. Patients received paclitaxel and carboplatin on day 1 of each twenty-one day cycle, with either REOLYSIN® administered on days 1 through 5. Fourteen patients were enrolled in the study. The primary objectives were tumour response, duration of response, and evidence of anti-tumour activity. The secondary objective was to assess the safety and tolerability of the treatment regimen.
Results from the study were presented by Oncolytics collaborators at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2011. Of the 13 patients evaluable for response, four had partial responses, for an objective response rate (complete response (CR) plus partial response (PR)) of 31%. Six patients had stable disease or better for 12 weeks or longer for a disease control rate (stable disease or better) of 46%. Two of the four patients with partial responses, and both patients with stable disease had received prior treatment with taxanes. By comparison, historical data assessing approved second-line therapies in chemotherapy-failed patients yielded response rates from 3% to 7%.
The study was conducted as an independent, confirmatory trial using the same treatment combination as the Company’s UK Phase II study, REO 011.